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Completed

NCT Number: NCT03481309

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Device

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

Cathodal tDCS

Device

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

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.

Primary outcomes

  1. 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.

  2. 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

  1. Changes in Resting-state EEG Dynamics Ratios

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

    The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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