ClinicalTrials.gg
CompletedNCT04731714MNSUpdated Oct 5, 2023Results posted

Median Nerve Stimulation Pilot

An interventional study of Rhythmic median nerve stimulation and Arrhythmic median nerve stimulation in Tourette Syndrome, Tic Disorders and Tic Disorder, Chronic Motor or Vocal, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 15 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
15 Years to 64 Years
Sex
All
01

Study summary

Results from the University of Nottingham suggested that rhythmic median nerve stimulation (MNS) improves tic symptoms in Tourette syndrome (TS). The investigators will (1) provide a first replication of their study, (2) test the hypothesized electrophysiological mechanism and rule out a placebo effect as cause for the symptomatic benefit, and (3) gather information on the duration of effect after the end of stimulation and on individual characteristics that predict improvement with simulation. Completion of these Aims will give a clear go/no-go signal for a future clinical trial of chronic MNS delivered by a yet-to-be-developed wristwatch-style device.

NOTE: This study is not intended to evaluate a specific device for future use. Rather it is a study to determine the action of pulsed electrical stimulation on tic symptoms and to gain early evidence of effectiveness. This is a non-significant risk device study.

Read the detailed description

Chronic tic disorders (CTD), including Tourette syndrome (TS), are associated with a substantially reduced quality of life. Medication treatments are no more than 50-60% effective in randomized controlled trials, and are often discontinued due to unacceptable side effects. Behavioral therapies require ability to participate in therapy and a specially trained therapist, but weekly visits to psychologists are impractical for many Americans, especially in rural areas. Patients strongly desire new treatment options.

In June, 2020, Stephen Jackson's group at the University of Nottingham published a fascinating report in Current Biology on a potential novel treatment for tics. The radical new idea arose from observations associating movement inhibition with 8-14 Hz activity in motor cortex. They first showed that rhythmic 12 Hz peripheral stimulation of the median nerve evoked synchronous contralateral EEG activity over primary sensorimotor cortex, whereas arrhythmic stimulation at the same mean rate did not. As hypothesized, median nerve stimulation (MNS) at 12 Hz created small but statistically significant effects on initiation of voluntary movements. Importantly, they also demonstrated that this stimulation did not meaningfully impair concentration, suggesting that the effect did not operate through simple distraction. They went on to test 10 Hz MNS in 19 TS patients, and demonstrated using blinded video ratings a significant reduction in tic number and severity during 1-minute stimulation epochs vs 1-minute no-stimulation epochs. They noted that in some participants, benefit lasted beyond the end of the stimulation epoch. Videos accompanying the publication showed dramatic benefit during MNS in some subjects. Although the authors appropriately noted the steps needed to generalize these results to clinical practice, news reports already have led a number of TS patients to contact them asking for treatment. The Nottingham group has referred such inquiries from the U.S. to me as leader of our Wash.U. Tourette Association of America (TAA) Center of Excellence.

The hypotheses of this project are that the tic benefits reported by the Nottingham investigators are replicable, that they are specific to rhythmic stimulation, which alone entrained cortical activity, rather than to a placebo effect, and that they endure past the end of stimulation.

This project (a) will replicate the Nottingham findings using identical methods, and (b) will test rhythmic MNS against a placebo treatment (arrhythmic MNS at the same mean frequency). It also will gather additional preliminary data needed for a future R01 application, including response and tolerability with longer (5-minute) stimulation blocks, and the duration of benefit after the end of a stimulation block.

02

Conditions studied

  • Tourette Syndrome
  • Tic Disorders
  • Tic Disorder, Chronic Motor or Vocal

Keywords

  • Tourette
  • Tic
  • Transcutaneous Electric Nerve Stimulation
  • Median Nerve
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 34 is close to the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 15-64 inclusive at initial screening visit
  • by adult subject; assent by child and informed consent by guardian
  • Current Tourette's Disorder or Persistent (Chronic) Tic Disorder according to the criteria in the , 5th Edition: DSM-5
  • At least 1 tic per minute (average) during the first 5-min. baseline video session on the first visit (as scored during the session by the investigator)

Exclusion criteria

Exclusion Criteria:

  • Unable to complete study procedures for any reason
  • Has an implanted device that could be affected by electrical current
  • Pregnancy known to participant or (for children) to the parent
  • Known or suspected primary genetic syndrome (e.g. Down syndrome, Fragile X)
  • Intellectual disability (known, or likely from history and examination)
  • Head trauma with loss of consciousness for more than 5 minutes
  • Significant neurologic disease, not counting TS (exceptions include febrile seizures or uncomplicated migraine)
  • Severe or unstable systemic illness
  • Factors (such as exaggerated signs) that in the judgment of the principal investigator make the video recording or YGTSS an inaccurate assessment of tic severity
  • Judged by investigator to be unlikely to complete study procedures or to return for later visits
  • Change in somatic or psychotherapeutic treatment in the 2 weeks preceding the first stimulation visit
  • Planned change in somatic or psychotherapeutic treatment between the 2 stimulation visits
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Other
    Experimental: rhythmic MNS, then arrhythmic MNS

    Participants will complete two stimulation sessions, at least a week apart. The first session involves rhythmic MNS and the second uses arrhythmic MNS.

    Device: Rhythmic median nerve stimulation · Device: Arrhythmic median nerve stimulation

  • Other
    Experimental: arrhythmic MNS, then rhythmic MNS

    Participants will complete two stimulation sessions, at least a week apart. The first session involves arrhythmic MNS and the second uses rhythmic MNS.

    Device: Rhythmic median nerve stimulation · Device: Arrhythmic median nerve stimulation

Interventions

  • DeviceRhythmic median nerve stimulation

    Square-wave 200 µs pulses triggered by computer at 12 Hz, at the threshold for thumb movement (expected \~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.

    Also known as: Rhythmic MNS

  • DeviceArrhythmic median nerve stimulation

    Square-wave 200 µs pulses triggered by computer at random intervals with a mean rate of 12 Hz (as described in Morera Maiquez et al., 2020), at the threshold for thumb movement (expected \~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.

    Also known as: Arrhythmic MNS

06

What researchers measure

Primary outcomes

  1. Change in Tic Frequency From When MNS is Turned Off

    The number of tics per minute is assessed by an expert rater blind to condition and time point. Mean tic frequency was compared in on vs. off 1-minute stimulation epochs on the rhythmic MNS day. This analysis replicates that of Study 3 in the Morera Maiquez et al 2020 citation, who reported tics in the last 40 seconds of the block to minimize carryover effects. A Mixed Models Analysis was used to test statistical significance; it included a factor for possible within-day carryover effect and used a logarithmic transformation for tic count. Data reported here have been back-transformed to the number of tics in the last 40 s of the stimulation blocks.

    Time frame: During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)

  2. Change in Tic Severity From When MNS is Turned Off

    Severity is rated on a 5-point scale for each occurrence of any tic. The scale is the Intensity item from the Yale Global Tic Severity Scale \[YGTSS\], which uses integer scores from 0 (no tics) to 5 (severe intensity). Mean tic severity was compared in on vs. off 1-minute stimulation epochs on the rhythmic MNS day. This analysis replicates that of Study 3 in the Morera Maiquez et al 2020 citation.

    Time frame: During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)

  3. Change in Tic Frequency During Rhythmic MNS (vs. Arrhythmic MNS)

    The number of tics per minute is assessed by an expert rater blind to condition and time point. Change in tic frequency from baseline (stimulation off) is compared between 5-minute MNS-on epochs on the rhythmic vs. the arrhythmic day. Subjects who do not complete both stimulation visits will not be included in this analysis. The hypothesized change is greater improvement (off to on) with rhythmic vs. arrhythmic stimulation. This analysis includes the first six 5-minute blocks on each MNS day (i.e., the blocks that all participants complete). MNS was administered throughout blocks 6 and 8 only. Tic frequency in block 0 (baseline, before any stimulation) on the same day was a covariate in the statistical model.

    Time frame: During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9

  4. Change in Tic Severity During Rhythmic MNS (vs. Arrhythmic MNS)

    Overall tic severity for each 5-minute block is rated once on a 5-point scale by an expert blind to condition and time point. The scale is the Intensity item from the Yale Global Tic Severity Scale \[YGTSS\], which uses integer scores from 0 (no tics) to 5 (severe intensity). Change in tic severity from baseline (stimulation off) is compared between 5-minute MNS-on epochs on the rhythmic vs. the arrhythmic day. Subjects who do not complete both stimulation visits will not be included in this analysis. The hypothesized change was greater improvement (off to on) with rhythmic vs. arrhythmic stimulation. This analysis includes the first six 5-minute blocks on each MNS day (i.e., the blocks that all participants complete). MNS was administered throughout blocks 6 and 8 only. Tic frequency in block 0 (baseline, before any stimulation) on the same day was a covariate in the statistical model.

    Time frame: During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9

Secondary outcomes

  1. Change in Tic Severity After MNS Ends

    We compared the change in tic frequency from baseline, during each 1-minute-long period following the end of stimulation. Here baseline means the tic frequency during the last 5 minutes of MNS from the same day (block 8). Last observation carried forward was used for participants who had less than 20 minutes of data following block 8.

    Time frame: up to 20 minutes after the end of stimulation at each study visit up to 1 month

  2. CGI-I, Participant

    Clinical Global Impression of Improvement (CGI-I), rated by participant. The CGI-I is a 7-point scale ranging from 1 = very much improved to 7 = very much worse.

    Time frame: 5-25 minutes after the end of stimulation at each study visit up to 1 month

  3. CGI-I, Investigator

    Clinical Global Impression of Improvement (CGI-I), rated by investigator. The CGI-I is a 7-point scale ranging from 1 = very much improved to 7 = very much worse.

    Time frame: 5-25 minutes after the end of stimulation at each study visit up to 1 month

  4. Rating of Therapeutic Effect Using the CGI Efficacy Index

    Participant rates peak improvement experienced during the visit using the 4-point scale of the CGI (Unchanged or worse; Minimal - Slight improvement that doesn't decrease the overall impact of symptoms\*; Moderate - Decided improvement. Partial remission of symptoms; Marked - Vast improvement. Complete or nearly complete remission of all symptoms). \* = "Minimal" option anchor text slightly edited from original. The number provided is the number of participants who rated each visit as moderate or marked.

    Time frame: 5-25 minutes after the end of stimulation at each study visit up to 1 month

  5. VAS (Visual Analog Scale) Rating of Premonitory Urge Severity

    Participant rates the maximal severity of any premonitory urges over the preceding minute, from 0=no premonitory urge to 100=maximally uncomfortable premonitory urge, using a Visual Analog Scale.

    Time frame: At the end of each 5-min. MNS on or off block through block 9, at each study visit

  6. Rating of Discomfort Using the CGI Efficacy Index (Edited)

    Participant rates peak discomfort experienced during the visit using the 4-point scale of the CGI: "Overall, today, how much DISCOMFORT did the stimulation cause? If discomfort is the wrong word, please substitute any negative effects or side effects of stimulation. (No discomfort; Discomfort noticeable, but not severe enough to concern me or to turn it off; Enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable; Caused discomfort, impairment of functioning or social embarrassment to a degree that any treatment benefit was not worth leaving it on). The number provided is the number of visits where discomfort is rated as none or minimal.

    Time frame: 5-25 minutes after the end of stimulation at each study visit up to 1 month

  7. Blindedness Assessment

    Participants guess at each study visit whether they received the active or sham MNS condition, and rate their certainty for that guess on a 0-3 scale (0 = pure guess, 3 = certain). The number reported here is the number of visits for which the participant guessed correctly (active vs. sham MNS).

    Time frame: 5-25 minutes after the end of stimulation at each study visit up to 1 month

07

Results

Posted Oct 5, 2023
Limitations and caveats
We did not test other variations on MNS, so we cannot address the specificity of the median nerve (vs. any other peripheral nerve), the specificity of 10-12 Hz as the stimulation frequency, or whether there is a lateral preference for MNS benefit.

Participant flow

Participants were recruited through clinical referrals, referrals from the University of Nottingham research team, advertising and word of mouth. Recruitment began in June, 2021, with the first subject enrolled in July, 2021. Study completion was in April, 2022.

Participant flow — Overall Study
MilestoneExperimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNS
Started1616
Completed study visit 11616
Completed study visit 21616
Completed1616
Not completed00

Outcome measures

PrimaryChange in Tic Frequency From When MNS is Turned Off

The number of tics per minute is assessed by an expert rater blind to condition and time point. Mean tic frequency was compared in on vs. off 1-minute stimulation epochs on the rhythmic MNS day. This analysis replicates that of Study 3 in the Morera Maiquez et al 2020 citation, who reported tics in the last 40 seconds of the block to minimize carryover effects. A Mixed Models Analysis was used to test statistical significance; it included a factor for possible within-day carryover effect and used a logarithmic transformation for tic count. Data reported here have been back-transformed to the number of tics in the last 40 s of the stimulation blocks.

Time frame:
During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)
Reported as:
Least squares mean · Tic frequency (number of tics in 40 s)
Change in Tic Frequency From When MNS is Turned Off
Tic frequency (number of tics in 40 s)All Participants
Stimulation Off12.1 (9.3 to 15.8)
Stimulation On8.9 (6.6 to 11.8)
Statistical analysis
  • All Participants · Mixed Models Analysis · p = 0.0104See publication for details
PrimaryChange in Tic Severity From When MNS is Turned Off

Severity is rated on a 5-point scale for each occurrence of any tic. The scale is the Intensity item from the Yale Global Tic Severity Scale \[YGTSS\], which uses integer scores from 0 (no tics) to 5 (severe intensity). Mean tic severity was compared in on vs. off 1-minute stimulation epochs on the rhythmic MNS day. This analysis replicates that of Study 3 in the Morera Maiquez et al 2020 citation.

Time frame:
During the 1-minute on and 1-minute off blocks of rhythmic MNS stimulation (total 4 blocks)
Reported as:
Least squares mean · units on a scale
Change in Tic Severity From When MNS is Turned Off
units on a scaleAll Participants
Stimulation Off2.5 (2.2 to 2.7)
Stimulation On2.3 (2.0 to 2.6)
Statistical analysis
  • All Participants · Mixed Models Analysis · p = 0.079See publication for details
PrimaryChange in Tic Frequency During Rhythmic MNS (vs. Arrhythmic MNS)

The number of tics per minute is assessed by an expert rater blind to condition and time point. Change in tic frequency from baseline (stimulation off) is compared between 5-minute MNS-on epochs on the rhythmic vs. the arrhythmic day. Subjects who do not complete both stimulation visits will not be included in this analysis. The hypothesized change is greater improvement (off to on) with rhythmic vs. arrhythmic stimulation. This analysis includes the first six 5-minute blocks on each MNS day (i.e., the blocks that all participants complete). MNS was administered throughout blocks 6 and 8 only. Tic frequency in block 0 (baseline, before any stimulation) on the same day was a covariate in the statistical model.

Time frame:
During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9
Reported as:
Least squares mean · Tic frequency (number of tics in 5 min.)
Change in Tic Frequency During Rhythmic MNS (vs. Arrhythmic MNS)
Tic frequency (number of tics in 5 min.)All Participants
Arrhythmic Block 585.8 (69.2 to 102.4)
Arrhythmic Block 663.3 (46.5 to 80.2)
Arrhythmic Block 774.2 (57.3 to 91.2)
Arrhythmic Block 857.7 (40.8 to 74.5)
Arrhythmic Block 965.0 (48.4 to 81.6)
Rhythmic Block 585.9 (69.7 to 102.1)
Rhythmic Block 661.8 (45.4 to 78.2)
Rhythmic Block 767.5 (51.0 to 83.9)
Rhythmic Block 857.6 (41.2 to 74.0)
Rhythmic Block 968.4 (52.2 to 84.7)
Statistical analysis
  • All Participants · Mixed Models Analysis · p = 0.9222See publication for details
PrimaryChange in Tic Severity During Rhythmic MNS (vs. Arrhythmic MNS)

Overall tic severity for each 5-minute block is rated once on a 5-point scale by an expert blind to condition and time point. The scale is the Intensity item from the Yale Global Tic Severity Scale \[YGTSS\], which uses integer scores from 0 (no tics) to 5 (severe intensity). Change in tic severity from baseline (stimulation off) is compared between 5-minute MNS-on epochs on the rhythmic vs. the arrhythmic day. Subjects who do not complete both stimulation visits will not be included in this analysis. The hypothesized change was greater improvement (off to on) with rhythmic vs. arrhythmic stimulation. This analysis includes the first six 5-minute blocks on each MNS day (i.e., the blocks that all participants complete). MNS was administered throughout blocks 6 and 8 only. Tic frequency in block 0 (baseline, before any stimulation) on the same day was a covariate in the statistical model.

Time frame:
During 5-minute MNS stimulation on or off blocks 0, 5, 6, 7, 8 and 9
Reported as:
Least squares mean · units on a scale
Change in Tic Severity During Rhythmic MNS (vs. Arrhythmic MNS)
units on a scaleAll Participants
Arrhythmic Block 53.4 (3.1 to 3.6)
Arrhythmic Block 63.2 (2.9 to 3.5)
Arrhythmic Block 73.4 (3.1 to 3.6)
Arrhythmic Block 83.0 (2.7 to 3.3)
Arrhythmic Block 93.1 (2.8 to 3.3)
Rhythmic Block 53.3 (3.0 to 3.6)
Rhythmic Block 63.2 (2.9 to 3.4)
Rhythmic Block 73.2 (2.9 to 3.5)
Rhythmic Block 83.1 (2.8 to 3.3)
Rhythmic Block 93.1 (2.8 to 3.3)
Statistical analysis
  • All Participants · Mixed Models Analysis · p = 0.7995See publication for details
SecondaryChange in Tic Severity After MNS Ends

We compared the change in tic frequency from baseline, during each 1-minute-long period following the end of stimulation. Here baseline means the tic frequency during the last 5 minutes of MNS from the same day (block 8). Last observation carried forward was used for participants who had less than 20 minutes of data following block 8.

Time frame:
up to 20 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Median · Tic frequency (tics per minute)
Change in Tic Severity After MNS Ends
Tic frequency (tics per minute)All Participants
Final Block Of Stimulation, rhythmic days7.1 (3.95 to 12.4)
20 minutes after stimulation, rhythmic days12 (5 to 17.75)
Final Block Of Stimulation, arrhythmic days8 (3.7 to 18.7)
20 minutes after stimulation, arrhythmic days10 (5 to 22)
Statistical analysis
  • All Participants · Friedman Test · p = 0.3140 (rhythmic days)See publication for further details
  • All Participants · Friedman Test · p = 0.239 (arrhythmic days)See publication for further details
SecondaryCGI-I, Participant

Clinical Global Impression of Improvement (CGI-I), rated by participant. The CGI-I is a 7-point scale ranging from 1 = very much improved to 7 = very much worse.

Time frame:
5-25 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Mean · units on a scale
CGI-I, Participant
units on a scaleAll Participants
Rhythmic Day2.69 ± 1.03
Arrhythmic Day2.39 ± 0.99
SecondaryCGI-I, Investigator

Clinical Global Impression of Improvement (CGI-I), rated by investigator. The CGI-I is a 7-point scale ranging from 1 = very much improved to 7 = very much worse.

Time frame:
5-25 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Mean · units on a scale
CGI-I, Investigator
units on a scaleAll Participants
Rhythmic Day2.41 ± 0.91
Arrhythmic Day2.56 ± 1.01
SecondaryRating of Therapeutic Effect Using the CGI Efficacy Index

Participant rates peak improvement experienced during the visit using the 4-point scale of the CGI (Unchanged or worse; Minimal - Slight improvement that doesn't decrease the overall impact of symptoms\*; Moderate - Decided improvement. Partial remission of symptoms; Marked - Vast improvement. Complete or nearly complete remission of all symptoms). \* = "Minimal" option anchor text slightly edited from original. The number provided is the number of participants who rated each visit as moderate or marked.

Time frame:
5-25 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Count of participants · Participants
Rating of Therapeutic Effect Using the CGI Efficacy Index
ParticipantsAll Participants
Rhythmic Day20
Arrhythmic Day23
SecondaryVAS (Visual Analog Scale) Rating of Premonitory Urge Severity

Participant rates the maximal severity of any premonitory urges over the preceding minute, from 0=no premonitory urge to 100=maximally uncomfortable premonitory urge, using a Visual Analog Scale.

Time frame:
At the end of each 5-min. MNS on or off block through block 9, at each study visit
Reported as:
Mean · units on a scale
VAS (Visual Analog Scale) Rating of Premonitory Urge Severity
units on a scaleAll Participants
Arrhythmic Block 550.1 (43.7 to 56.6)
Arrhythmic Block 636.5 (30.0 to 43.1)
Arrhythmic Block 743.0 (36.5 to 49.6)
Arrhythmic Block 832.0 (25.4 to 38.7)
Arrhythmic Block 938.4 (31.9 to 45.0)
Rhythmic Block 550.3 (43.8 to 56.8)
Rhythmic Block 634.1 (27.6 to 40.7)
Rhythmic Block 745.5 (39.0 to 52.1)
Rhythmic Block 832.8 (26.3 to 39.4)
Rhythmic Block 940.5 (34.1 to 47.0)
Statistical analysis
  • All Participants · Mixed Models Analysis · p = 0.8844See publication for details
SecondaryRating of Discomfort Using the CGI Efficacy Index (Edited)

Participant rates peak discomfort experienced during the visit using the 4-point scale of the CGI: "Overall, today, how much DISCOMFORT did the stimulation cause? If discomfort is the wrong word, please substitute any negative effects or side effects of stimulation. (No discomfort; Discomfort noticeable, but not severe enough to concern me or to turn it off; Enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable; Caused discomfort, impairment of functioning or social embarrassment to a degree that any treatment benefit was not worth leaving it on). The number provided is the number of visits where discomfort is rated as none or minimal.

Time frame:
5-25 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Count of units · Visits
Rating of Discomfort Using the CGI Efficacy Index (Edited)
VisitsAll Participants
Rating of Discomfort Using the CGI Efficacy Index (Edited)57
SecondaryBlindedness Assessment

Participants guess at each study visit whether they received the active or sham MNS condition, and rate their certainty for that guess on a 0-3 scale (0 = pure guess, 3 = certain). The number reported here is the number of visits for which the participant guessed correctly (active vs. sham MNS).

Time frame:
5-25 minutes after the end of stimulation at each study visit up to 1 month
Reported as:
Count of units · treatment guess on a given study visit
Blindedness Assessment
treatment guess on a given study visitAll Participants
Guessed correctly30
Guessed incorrectly34
Statistical analysis
  • All Participants · binomial · p = 0.73One-sided

Adverse events

Collected over From enrollment through final study visit, up to 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental: Rhythmic MNS0/32 (0%)0/32 (0%)4/32 (12.5%)
Experimental: Arrhythmic MNS0/32 (0%)0/32 (0%)3/32 (9.4%)
Most frequent other events
Showing 2 of 3
Most frequent other events
EventExperimental: Rhythmic MNSExperimental: Arrhythmic MNS
HeadacheNervous system disorders1/320/32
ItchNervous system disorders1/320/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNSTotal
Mean36.81 ± 16.8131.25 ± 16.1634.03 ± 16.51
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNSTotal
Female4711
Male12921
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNSTotal
Hispanic or Latino011
Not Hispanic or Latino161531
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNSTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American011
White151429
More than one race011
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Experimental: Rhythmic MNS, Then Arrhythmic MNSExperimental: Arrhythmic MNS, Then Rhythmic MNSTotal
United States161632
08

Study locations

1 site
  • Washington University School of Medicine, Movement Disorders Center
    Saint Louis, Missouri 63110, United States
09

References and documents

Publications

  • Morera Maiquez B, Sigurdsson HP, Dyke K, Clarke E, McGrath P, Pasche M, Rajendran A, Jackson GM, Jackson SR. Entraining Movement-Related Brain Oscillations to Suppress Tics in Tourette Syndrome. Curr Biol. 2020 Jun 22;30(12):2334-2342.e3. doi: 10.1016/j.cub.2020.04.044. Epub 2020 Jun 4. PubMed 32502412 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Video recordings will not be shared, as they cannot feasibly be de-identified. All other individual participant data (excluding PHI) will be collected and stored on REDCap (redcap.wustl.edu) and will be shared on the Open Science Framework (OSF, at https://osf.io/mtbzf/).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The study protocol is available now (https://osf.io/mtbzf/). Statistical Analysis Plan (SAP) will be available before enrolling the first participant.

Access criteria: Individual participant data (IPD) will be freely available under a CC0 license (Creative Commons public domain dedication, https://creativecommons.org/publicdomain/zero/1.0/).

Data sharing details ↗ · osf.io

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04731714
Responsible party
Kevin J. Black, M.D. (Principal Investigator, Washington University School of Medicine) — Principal investigator
First posted
Feb 1, 2021
Start date
Jul 15, 2021
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022
Results posted
Oct 5, 2023
Last update
Oct 5, 2023

Study contacts

Kevin J Black, MD
principal investigator · Washington University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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