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The purpose of this study is to determine the optimal transcranial direct current stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability of targeted brain regions. Various studies have investigated tDCS use in stroke patients with motor impairments (cumulatively about 200 cases). Although these studies are mostly "proof of concept" with small sample size, they do suggest that tDCS may improve motor function. However these two questions have not been addressed systematically:
This proposal lays the scientific foundation for systematic application of tDCS in stroke recovery research by progressively increasing tDCS currents and montages that are both safe and efficacious in population with stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Determine the Optimal tDCS current | Experimental | We will invesitigate the optimal curent in range of 1 mA to 4 mA. We hypothesize that 4 mA is tolerable, safe and can induce the highest level of cortical excitability in the lesional motor cortex. |
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| Determine the optimal tDCS electrode montage | Experimental | We hypothesize that the bi-hemispheric stimulation with anodal stimulation on the lesional hemisphere and simultaneous cathodal stimulation on the non-lesional hemisphere induces more cortical excitability in the lesional hemisphere than either anodal stimulation on the affected hemisphere or cathodal stimulation on non-lesional hemisphere alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Response | Major response is any of the following:
In a 3+3 design, 3 subjects are recruited for a given tDCS dose level. The trial is stopped if ≥2 of 3 subjects at a given tDCS dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given tDCS dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next tDCS dose level. Maximum tolerable dose will be the tDCS dose at the level before stopping of the trial. | Immediately after intervention on the day of tDCS application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wuwei Feng, MD, MS | MEDICAL UNIVERSITY OF SOUTH CAROL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28279641 | Derived | Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May-Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27. |
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Part 1 was a 3+3 dose-escalation study, which allowed up to 6 participants at a given dose escalation step. Part 2 was a montage effect study, which was a cross-over study requiring 18 participants to finish the study (by completing 3 visits). Participants enrolled in Part 1 were allowed to be enrolled in Part 2, but repeat participation in the same part by the same subject was not allowed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 1 mA with bihemispheric montage |
| FG001 | 2 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 2 mA with bihemispheric montage |
| FG002 | 2.5 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 2.5 mA with bihemispheric montage |
| FG003 | 3 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 3 mA with bihemispheric montage |
| FG004 | 3.5 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 3.5 mA with bihemispheric montage |
| FG005 | 4 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 4 mA with bihemispheric montage |
| FG006 | 4 mA Anodal tDCS | Subjects will get tDCS at a current of 4 mA with anodal montage |
| FG007 | 4 mA Cathodal tDCS | Subjects will get tDCS at a current of 4 mA with cathodal montage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Dose Escalation, 1 mA |
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| Part 1 Dose Escalation, 2 mA |
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| Part 1 Dose Escalation, 2.5 mA |
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| Part 1 Dose Escalation, 3 mA |
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| Part 1 Dose Escalation, 3.5 mA |
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| Part 1 Dose Escalation, 4 mA |
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| Part 2 Montage Effect, 1st Intervention |
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| Part 2 Montage Effect, 2nd Intervention |
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| Part 2 Montage Effect, 3rd Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mA Bihemispheric tDCS | Participants received 1 mA Bihemispheric tDCS |
| BG001 | 2 mA Bihemispheric tDCS | Participants received 2 mA Bihemispheric tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period. |
| 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 | Number of Participants With Major Response | Major response is any of the following:
In a 3+3 design, 3 subjects are recruited for a given tDCS dose level. The trial is stopped if ≥2 of 3 subjects at a given tDCS dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given tDCS dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next tDCS dose level. Maximum tolerable dose will be the tDCS dose at the level before stopping of the trial. | Posted | Count of Participants | Participants | Immediately after intervention on the day of tDCS application |
|
4 years, 4 months
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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 | 1 mA Bihemispheric tDCS | Subjects will receive tDCS at 1 mA with bihemispheric montage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Hutchison, Manager of COBRE Research Operations | Medical University or SC | 843-792-2712 | hutchis@musc.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 | Feb 3, 2017 | Jun 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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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| 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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| 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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| BG002 | 2.5 mA Bihemispheric tDCS | Participants received 2.5 mA Bihemispheric tDCS |
| BG003 | 3 mA Bihemispheric tDCS | Participants received 3 mA Bihemispheric tDCS |
| BG004 | 3.5 mA Bihemispheric tDCS | Participants received 3.5 mA Bihemispheric tDCS |
| BG005 | 4 mA Bihemispheric tDCS | Participants received 4 mA Bihemispheric tDCS |
| BG006 | Crossover - 4mA Bihemisphere tDCS and 4 mA Anodal tDCS and 4mA Cathodal tDCS | Stroke subjects will each receive one of three stimulation montages |
| BG007 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period. | Count of Participants | Participants |
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| Race (NIH/OMB) | Measure Analysis Population Description: Dose escalation does not include Crossover period, Crossover period foes not include Dose Escalation period. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Subjects will get tDCS at a current of 1 mA with bihemispheric montage |
| OG001 | 2 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 2 mA with bihemispheric montage |
| OG002 | 2.5 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 2.5 mA with bihemispheric montage |
| OG003 | 3 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 3 mA with bihemispheric montage |
| OG004 | 3.5 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 3.5 mA with bihemispheric montage |
| OG005 | 4 mA Bihemispheric tDCS | Subjects will get tDCS at a current of 4 mA with bihemispheric montage |
| OG006 | 4 mA Anodal tDCS | Subjects will get tDCS at a current of 4 mA with anodal montage |
| OG007 | 4 mA Cathodal tDCS | Subjects will get tDCS at a current of 4 mA with cathodal montage |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 2 mA Bihemispheric tDCS | Subjects will receive tDCS at 2 mA with bihemispheric montage | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | 2.5 mA Bihemispheric tDCS | Subjects will receive tDCS at 2.5 mA with bihemispheric montage | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | 3 mA Bihemispheric tDCS | Subjects will receive tDCS at 3.0 mA with bihemispheric montage | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | 3.5 mA Bihemispheric tDCS | Subjects will receive tDCS at 3.5 mA with bihemispheric montage | 1 | 3 | 0 | 3 | 0 | 3 |
| EG005 | 4 mA Bihemispheric tDCS | Subjects will receive tDCS at 4 mA with bihemispheric montage | 0 | 21 | 0 | 21 | 0 | 21 |
| EG006 | 4 mA Anodal tDCS | Subjects will receive tDCS at 4 mA with anodal montage | 0 | 18 | 0 | 18 | 0 | 18 |
| EG007 | 4 mA Cathodal tDCS | Subjects will receive tDCS at 4 mA with cathodal montage | 0 | 19 | 0 | 19 | 0 | 19 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Crossover Period |
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