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

NCT ID: NCT03481309

Last Updated: 2021-03-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2019-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Motor Activity Motor Neuroplasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will be assigned to 2 active and sham conditions on a different day.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This is a double-blind and cross-over study.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

anodal tDCS

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

cathodal tDCS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

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.

Interventions

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anodal tDCS

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

Intervention Type DEVICE

cathodal tDCS

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

Intervention Type DEVICE

sham 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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, HIV/AIDS, malignancy, 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flavio Frohlich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill - Department of Psychiatry

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01MH101547

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0149

Identifier Type: -

Identifier Source: org_study_id

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