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CompletedNCT03304262Updated Aug 25, 2023Results posted

Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change

An interventional study of rTMS in Healthy, sponsored by University of New Mexico. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by University of New Mexico · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.

Read the detailed description

The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.

02

Conditions studied

  • Healthy

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Keywords

  • Metaplasticity
  • Motor excitability
  • rTMS
  • tDCS
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be at least 18 years of age (all genders, races, ethnicity)
  • Must have no current psychiatric or neurologic issues
  • Must not have any conditions listed in exclusion criteria
  • Must be fluent in English

Exclusion criteria

Exclusion Criteria:

  • History of major psychiatric illness
  • Actively using neuropsychoactive medication
  • Legal or mental incompetency
  • Substance use disorder, abuse or dependence, with active use within the last three months
  • Significant medical or neurological illness
  • Prior neurosurgical illness
  • Prior neurosurgical procedure
  • History of seizure
  • History of ECT or TMS treatment within the past there months
  • Presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink)
  • Pregnant women
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS

    Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

    Device: rTMS

  • Active comparator
    Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS

    Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

    Device: rTMS

  • Sham comparator
    Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS

    Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.

    Device: rTMS

Interventions

  • DevicerTMS

    Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.

    Also known as: rapid transcranial magnetic stimulation

05

What researchers measure

Primary outcomes

  1. Percent Change in MEP Amplitude

    Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand

    Time frame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes

Secondary outcomes

  1. Cortical Silent Period

    Change in length of CSP

    Time frame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)

  2. Simple Reaction Time

    Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.

    Time frame: The final outcome will be percent change in the reaction time from pre- to post- intervention.

06

Results

Posted Aug 25, 2023

Participant flow

Participant flow — Overall Study
MilestoneCathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS
Started454
Completed454
Not completed000

Outcome measures

PrimaryPercent Change in MEP Amplitude

Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand

Time frame:
assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Reported as:
Mean · Percent Change
Percent Change in MEP Amplitude
Percent ChangeCathodal tDCS + rTMSAnodal tDCS + rTMSSham tDCS + rTMS
Percent Change in MEP Amplitude1.19 (0.43 to 5.65)1.06 (0.33 to 2.03)1.38 (0.19 to 2.82)
SecondaryCortical Silent Period

Change in length of CSP

Time frame:
tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Reported as:
Mean · Percent change
Cortical Silent Period
Percent changeCathodal tDCS + rTMSAnodal tDCS + rTMSSham tDCS + rTMS
Cortical Silent Period1.02 (0.88 to 1.23)1.01 (0.88 to 1.13)0.99 (.88 to 1.08)
SecondarySimple Reaction Time

Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.

Time frame:
The final outcome will be percent change in the reaction time from pre- to post- intervention.
Reported as:
Mean · Percent change
Simple Reaction Time
Percent changeCathodal tDCS + rTMSAnodal tDCS + rTMSSham tDCS + rTMS
Simple Reaction Time1.01 (0.94 to 1.15)1.02 (0.91 to 1.19)1.02 (0.9 to 1.16)

Adverse events

Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cathodal tDCS + rTMS0/13 (0%)0/13 (0%)0/13 (0%)
Anodal tDCS + rTMS0/13 (0%)0/13 (0%)0/13 (0%)
Sham tDCS + rTMS0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMSTotal
Mean35.54 (23 to 52)35.54 (28 to 46)35.54 (25 to 36)35.54 (23 to 52)
Sex: Female, Male
Sex: Female, Male(Participants)Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMSTotal
Female2428
Male2125
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMSTotal
Hispanic or Latino2338
Not Hispanic or Latino2215
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMSTotal
American Indian or Alaska Native0011
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White3429
More than one race1012
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMSAnodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMSSham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMSTotal
United States45413
07

Study locations

1 site
  • University of New Mexico
    Albuquerque, New Mexico 87106, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 16, 2016
  • Informed consent form · Dec 16, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03304262
Lead sponsor
University of New Mexico
Responsible party
Sarah Pirio Richardson (Assistant Professor of Neurology, University of New Mexico) — Principal investigator
First posted
Oct 6, 2017
Start date
Jul 18, 2017
Primary completion
Feb 28, 2018
Completion
Mar 31, 2018
Results posted
Aug 25, 2023
Last update
Aug 25, 2023

Study contacts

Sarah Pirio Richardson, M.D.
principal investigator · University of New Mexico
Davin Quinn, M.D.
principal investigator · University of New Mexico

Oversight

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

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