ClinicalTrials.gg
CompletedNCT03481309Updated Mar 4, 2021Results posted

Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)

An interventional study of anodal tDCS and cathodal tDCS in Motor Activity and Motor Neuroplasticity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Motor Activity by University of North Carolina, Chapel Hill — 4 open to participants now, 4 under way, none of them phase 3. Motor Activity · University of North Carolina, Chapel Hill.

Enrollment
31st of 35
19 · median 78
Started
2018
with 1 other
No phase
34 of 35
4 open now
Registered
21st of 35
by date

Among the 35 studies in Motor Activity by University of North Carolina, Chapel Hill, this one is the 31st largest by enrollment, is one of 2 that started in 2018, is one of 34 with no phase, and was the 21st registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

4 of the 35 studies in Motor Activity by University of North Carolina, Chapel Hill are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 35 Years · male · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Motor Activity by University of North Carolina, Chapel Hill, or all of them as a file.
02

Study summary

Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.

Read the detailed description

Purpose of this pilot study is to modulate the motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation. Electromyography will be recorded on right abductor digiti minimi muscle to find the motor threshold and measure motor evoked potentials for each healthy participant. In addition, electroencephalography (EEG) data will be collected on the scalp with a high-density EEG net. Eighteen healthy participants will be in this study. Each participant will be seated in a reclining chair and applied non-invasive magnetic and electrical stimulations on the scalp. At baseline, the participant's resting motor threshold (RMT) will be estimated by adjusting the intensity of TMS applied on the left motor cortex to achieve motor-evoked potentials of about 50 uV with 10 TMS pulses at a rate of 0.25 Hz. Then a 3-condition, 3-session, 6-sequence randomized crossover experiment will be used to characterize and compare three versions of tDCS stimulation: anode, cathode, sham. Before and after a 10-min tDCS condition is applied, TMS pulses at 120% of RMT intensity will be applied for 10 minutes and TMS-evoked potential and motor-evoked potential amplitudes will be measured. Each session has at least 1-day gap to remove outlasting effects. We will also be collecting structural magnetic resonance imaging (sMRI) to target primary motor cortex precisely.

03

Conditions studied

  • Motor Activity
  • Motor Neuroplasticity

Browse trials for

Keywords

  • transcranial magnetic stimulation (TMS)
  • transcranial direct current stimulation (tDCS)
  • electroencephalography (EEG)
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

  • Male
  • Between the ages of 18 and 35
  • Right-handed
  • Capacity to understand all relevant risks and potential benefits of the study ()
  • Willing to comply with all study procedures and be available for the duration of the study
  • Speak and understand English

Exclusion criteria

Exclusion Criteria:

  • Prior concussion
  • Diagnosis of eating disorder (current or within the past 6 months)
  • Diagnosis of obsessive compulsive disorder (lifetime)
  • Attention-deficit/hyperactivity disorder (currently under treatment)
  • Neurological disorders and conditions, including, but not limited to:

    • History of epilepsy
    • Seizures (except childhood febrile seizures and electroconvulsive therapy-induced seizures)
    • Dementia
    • History of stroke
    • Parkinson's disease
    • Multiple sclerosis
    • Cerebral aneurysm
    • Brain tumors
  • Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, /AIDS, , liver or renal impairment)
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • Traumatic brain injury
  • Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Terms in these criteria, in plain language(3)

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    anodal tDCS

    Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This anodal tDCS on the left motor cortex will be stimulated with 2mA for 10 minutes.

    Device: anodal tDCS

  • Active comparator
    cathodal tDCS

    Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). This cathodal tDCS on the left motor cortex will be stimulated with -2mA for 10 minutes.

    Device: cathodal tDCS

  • Sham comparator
    sham tDCS

    Two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex). Sham stimulation with 2mA for 40 seconds will be applied.

    Device: sham tDCS

Interventions

  • Deviceanodal tDCS

    The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.

  • Devicecathodal tDCS

    The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.

  • Devicesham tDCS

    The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.

06

What researchers measure

Primary outcomes

  1. Changes in Motor-evoked Potentials Ratios

    The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.

    Time frame: right before and after 2mA tDCS stimulation for 10 minutes at each session

  2. Changes in TMS-evoked Potentials Ratios

    The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.

    Time frame: right before and after 2mA tDCS stimulation for 10 minutes at each session

Secondary outcomes

  1. Changes in Resting-state EEG Dynamics Ratios

    The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)

    Time frame: 4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session

07

Results

Posted Oct 23, 2019

Participant flow

First Intervention (1 Day)
Participant flow — First Intervention (1 Day)
MilestoneAnode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> Anode
Started433333
Completed433333
Not completed000000
Washout (at Least 3 Days)
Participant flow — Washout (at Least 3 Days)
MilestoneAnode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> Anode
Started433333
Completed333333
Not completed100000
Withdrew: Withdrawal by subject100000
Second Intervention (1 Day)
Participant flow — Second Intervention (1 Day)
MilestoneAnode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> Anode
Started333333
Completed333333
Not completed000000
Washout (at Least 3 Days)
Participant flow — Washout (at Least 3 Days)
MilestoneAnode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> Anode
Started333333
Completed333333
Not completed000000
Third Intervention (1 Day)
Participant flow — Third Intervention (1 Day)
MilestoneAnode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> Anode
Started333333
Completed333333
Not completed000000

Outcome measures

PrimaryChanges in Motor-evoked Potentials Ratios

The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.

Time frame:
right before and after 2mA tDCS stimulation for 10 minutes at each session
Reported as:
Mean · Ratio (unit: uV)
Changes in Motor-evoked Potentials Ratios
Ratio (unit: uV)Anodal tDCSCathodal tDCSSham tDCS
Changes in Motor-evoked Potentials Ratios1.32 ± 0.090.73 ± 0.071.03 ± 0.05
PrimaryChanges in TMS-evoked Potentials Ratios

The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.

Time frame:
right before and after 2mA tDCS stimulation for 10 minutes at each session
Reported as:
Mean · Ratio (unit: uV)
Changes in TMS-evoked Potentials Ratios
Ratio (unit: uV)Anodal tDCSCathodal tDCSSham tDCS
Changes in TMS-evoked Potentials Ratios1.5 ± 0.50.8 ± 0.41.1 ± 0.4
SecondaryChanges in Resting-state EEG Dynamics Ratios

The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)

Time frame:
4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session
Reported as:
Mean · Ratio (unit: uV)
Changes in Resting-state EEG Dynamics Ratios
Ratio (unit: uV)Anodal tDCSCathodal tDCSSham tDCS
Changes in Resting-state EEG Dynamics Ratios1.2 ± 0.70.8 ± 0.31.1 ± 0.5

Adverse events

Collected over After the study session on each day, an intervention was given, approximately 2 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anodal tDCS0/19 (0%)0/19 (0%)0/19 (0%)
Cathodal tDCS0/18 (0%)0/18 (0%)0/18 (0%)
Sham tDCS0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

One participant signed the consent form and provided baseline characteristics but research data collection for this participant was not performed.

Age, Categorical
Age, Categorical(Participants)Anode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> AnodeTotal
<=18 years0000000
Between 18 and 65 years43333319
>=65 years0000000
Age, Continuous
Age, Continuous(years)Anode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> AnodeTotal
Mean28.75 ± 6.6825.33 ± 6.9422.33 ± 1.2420.66 ± 0.4722 ± 4.2425.33 ± 6.1224.31 ± 5.84
Sex: Female, Male
Sex: Female, Male(Participants)Anode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> AnodeTotal
Female0000000
Male43333319
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Anode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> AnodeTotal
American Indian or Alaska Native0000000
Asian0010124
Native Hawaiian or Other Pacific Islander0000000
Black or African American1002104
White2211118
More than one race1110003
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(Participants)Anode -> Cathode -> ShamAnode -> Sham -> CathodeCathode -> Anode -> ShamCathode -> Sham -> AnodeSham -> Anode -> CathodeSham -> Cathode -> AnodeTotal
United States43333319
08

Study locations

1 site
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Jan 2019, 5 months.

Results were first posted in Oct 2019, 8 months after primary completion.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 5 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2018
First posted
Mar 29, 2018
StartActual
Aug 24, 2018
Primary completionActual
Jan 31, 2019
CompletionActual
Feb 1, 2019
Results first posted
Oct 23, 2019
Last update
Mar 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03481309
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Aug 24, 2018
Primary completion
Jan 31, 2019
Completion
Feb 1, 2019
Results posted
Oct 23, 2019
Last update
Mar 4, 2021

Study contacts

Flavio Frohlich, PhD
principal investigator · University of North Carolina at Chapel Hill - Department of Psychiatry

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 Feb 2021. You cannot join it, but the record below documents what was studied.

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