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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03481309
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Motor Activity; Motor Neuroplasticity	Device: anodal tDCS; Device: cathodal tDCS; Device: sham tDCS	N/A

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
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each participant will be assigned to 2 active and sham conditions on a different day.Each participant will be assigned to 2 active and sham conditions on a different day.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This is a double-blind and cross-over study.
• Primary Purpose: Basic Science
• Official Title: Modulation of Motor Cortex Excitability by Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
• Actual Study Start Date: Aug 24, 2018
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in Motor-evoked Potentials Ratios [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 [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 Outcome Measures

1. Changes in Resting-state EEG Dynamics Ratios [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Flavio Frohlich, PhD, University of North Carolina at Chapel Hill - Department of Psychiatry

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 26, 2018

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03481309
• Other Study ID Numbers: 17-0149; R01MH101547
• First Posted: Mar 29, 2018
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• 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
• Keywords provided by University of North Carolina, Chapel Hill: transcranial magnetic stimulation (TMS); transcranial direct current stimulation (tDCS); electroencephalography (EEG)

Study Results

Participant Flow

Arm/Group Title	Anode -> Cathode -> Sham	Anode -> Sham -> Cathode	Cathode -> Anode -> Sham	Cathode -> Sham -> Anode	Sham -> Anode -> Cathode	Sham -> Cathode -> Anode
Arm/Group Description	During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.
Period Title: First Intervention (1 Day)
STARTED	4	3	3	3	3	3
COMPLETED	4	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	1	0	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	3	3	3	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Anode -> Cathode -> Sham	Anode -> Sham -> Cathode	Cathode -> Anode -> Sham	Cathode -> Sham -> Anode	Sham -> Anode -> Cathode	Sham -> Cathode -> Anode	Total
Arm/Group Description	During 3 study visits, participants will receive anodal tDCS first, then cathodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive anodal tDCS first, then sham tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive cathodal tDCS first, then anodal tDCS, then sham tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive cathodal tDCS first, then sham tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive sham tDCS first, then anodal tDCS, then cathodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	During 3 study visits, participants will receive sham tDCS first, then cathodal tDCS, then anodal tDCS. For all three tDCS conditions, two electrodes will be applied to the scalp (one on the left motor cortex, one on the right supraorbital cortex) for 10 minutes.	Total of all reporting groups
Overall Participants	4	3	3	3	3	3	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	3 100%	3 100%	3 100%	3 100%	3 100%	19 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.75 (6.68)	25.33 (6.94)	22.33 (1.24)	20.66 (0.47)	22 (4.24)	25.33 (6.12)	24.31 (5.84)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	4 100%	3 100%	3 100%	3 100%	3 100%	3 100%	19 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	1 33.3%	0 0%	1 33.3%	2 66.7%	4 21.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 25%	0 0%	0 0%	2 66.7%	1 33.3%	0 0%	4 21.1%
White	2 50%	2 66.7%	1 33.3%	1 33.3%	1 33.3%	1 33.3%	8 42.1%
More than one race	1 25%	1 33.3%	1 33.3%	0 0%	0 0%	0 0%	3 15.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	4 100%	3 100%	3 100%	3 100%	3 100%	3 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Motor-evoked Potentials Ratios
Description	The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Time Frame	right before and after 2mA tDCS stimulation for 10 minutes at each session

Outcome Measure Data

Analysis Population Description

One participant signed the consent form but data for this participant was not recorded.

Arm/Group Title	Anodal tDCS	Cathodal tDCS	Sham tDCS
Arm/Group Description	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. anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.	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. cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.	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. 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.
Measure Participants	18	18	18
Mean (Standard Error) [Ratio (unit: uV)]	1.32 (0.09)	0.73 (0.07)	1.03 (0.05)

2. Primary Outcome

Title	Changes in TMS-evoked Potentials Ratios
Description	The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.
Time Frame	right before and after 2mA tDCS stimulation for 10 minutes at each session

Outcome Measure Data

Analysis Population Description

One participant signed the consent form but data for this participant was not recorded.

Arm/Group Title	Anodal tDCS	Cathodal tDCS	Sham tDCS
Arm/Group Description	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. anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.	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. cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.	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. 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.
Measure Participants	18	18	18
Mean (Standard Deviation) [Ratio (unit: uV)]	1.5 (0.5)	0.8 (0.4)	1.1 (0.4)

3. Secondary Outcome

Title	Changes in Resting-state EEG Dynamics Ratios
Description	The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)
Time Frame	4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session

Outcome Measure Data

Analysis Population Description

One participant signed the consent form but data for this participant was not recorded.

Arm/Group Title	Anodal tDCS	Cathodal tDCS	Sham tDCS
Arm/Group Description	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. anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.	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. cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.	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. 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.
Measure Participants	18	18	18
Mean (Standard Deviation) [Ratio (unit: uV)]	1.2 (0.7)	0.8 (0.3)	1.1 (0.5)

Adverse Events

Time Frame	After the study session on each day, an intervention was given, approximately 2 hours
Adverse Event Reporting Description	A side effects questionnaire
Arm/Group Title	Anodal tDCS		Cathodal tDCS		Sham tDCS
Arm/Group Description	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. anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.		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. cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.		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. 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.
All Cause Mortality
	Anodal tDCS		Cathodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)		0/18 (0%)
Serious Adverse Events
	Anodal tDCS		Cathodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Anodal tDCS		Cathodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.