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Clinical Trials/NCT03481309
NCT03481309CompletedNot Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country19 target enrollmentStarted: August 24, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Changes in Motor-evoked Potentials Ratios

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

This is a double-blind and cross-over study.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)
  • •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

Arms & Interventions

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.

Intervention: anodal tDCS (Device)

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.

Intervention: cathodal tDCS (Device)

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.

Intervention: sham tDCS (Device)

Outcomes

Primary Outcomes

Changes in Motor-evoked Potentials Ratios

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

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

Changes in TMS-evoked Potentials Ratios

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

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

Secondary Outcomes

  • Changes in Resting-state EEG Dynamics Ratios(4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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