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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH101547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anodal tDCS | Device | The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex. |
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| 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 |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich, PhD | University of North Carolina at Chapel Hill - Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anode -> Cathode -> Sham | 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. |
| FG001 | Anode -> Sham -> Cathode | 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. |
| FG002 | Cathode -> Anode -> Sham | 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. |
| FG003 | Cathode -> Sham -> Anode | 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. |
| FG004 | Sham -> Anode -> Cathode | 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. |
| FG005 | Sham -> Cathode -> Anode | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (at Least 3 Days) |
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| Second Intervention (1 Day) |
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| Washout (at Least 3 Days) |
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| Third Intervention (1 Day) |
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One participant signed the consent form and provided baseline characteristics but research data collection for this participant was not performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anode -> Cathode -> Sham | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One participant signed the consent form but data for this participant was not recorded. | Posted | Mean | Standard Error | Ratio (unit: uV) | right before and after 2mA tDCS stimulation for 10 minutes at each session |
|
After the study session on each day, an intervention was given, approximately 2 hours
A side effects questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. anodal tDCS: The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sangtae Ahn | University of North Carolina at Chapel Hill | 9195233127 | sangtae_ahn@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2018 | Aug 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Each participant will be assigned to 2 active and sham conditions on a different day.
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This is a double-blind and cross-over study.
| cathodal tDCS | Device | The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex. |
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| 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Anode -> Sham -> Cathode |
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. |
| BG002 | Cathode -> Anode -> Sham | 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. |
| BG003 | Cathode -> Sham -> Anode | 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. |
| BG004 | Sham -> Anode -> Cathode | 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. |
| BG005 | Sham -> Cathode -> Anode | 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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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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. |
| OG002 | 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. 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. |
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|
| 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. | One participant signed the consent form but data for this participant was not recorded. | Posted | Mean | Standard Deviation | Ratio (unit: uV) | right before and after 2mA tDCS stimulation for 10 minutes at each session |
|
|
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| 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) | One participant signed the consent form but data for this participant was not recorded. | Posted | Mean | Standard Deviation | Ratio (unit: uV) | 4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. cathodal tDCS: The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 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. 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |