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

Motor Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481309
• Other study ID #: 17-0149
• Secondary ID: R01MH101547
• Status: Completed
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Activity
• Motor Neuroplasticity

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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