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

Modulation of Motor Cortex Excitability by Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation

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

Study Overview

• Status: Completed
• Conditions: Motor Activity; Motor Neuroplasticity
• Intervention / Treatment: Device: anodal tDCS; Device: cathodal tDCS; Device: sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
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; The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation (tDCS); electroencephalography (EEG); transcranial magnetic stimulation (TMS)
• Other Study ID Numbers: 17-0149; R01MH101547 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No