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

NCT03481309 | Completed Results FDA Device

• 2 other identifiers: 17-0149R01MH101547
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Motor Activity; Motor Neuroplasticity

Keywords

transcranial magnetic stimulation (TMS); transcranial direct current stimulation (tDCS); electroencephalography (EEG)

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Changes in Resting-state EEG Dynamics Ratios

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

Study Arms (3)

anodal tDCS

ACTIVE COMPARATOR

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

cathodal tDCS

ACTIVE COMPARATOR

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 tDCS

SHAM COMPARATOR

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

anodal tDCS DEVICE

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

anodal tDCS

cathodal tDCS DEVICE

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

cathodal tDCS

sham tDCS 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.

sham tDCS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Sangtae Ahn
• Organization: University of North Carolina at Chapel Hill

sangtae_ahn@med.unc.edu

9195233127

Study Officials

• Flavio Frohlich, PhD

  University of North Carolina at Chapel Hill - Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind and cross-over study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be assigned to 2 active and sham conditions on a different day.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 29, 2018
• Study Start: August 24, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 1, 2019
• Last Updated: March 4, 2021
• Results First Posted: October 23, 2019

Record last verified: 2021-02

Locations

US (1)