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| Name | Class |
|---|---|
| Minnesota Medical Foundation | OTHER |
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The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Receiving active tDCS |
|
| Sham tDCS | Sham Comparator | tDCS equipment set to placebo setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | transcranial direct current stimulation- non-invasive brain stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events/Safety Assessment. | Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:
Detailed adverse events are reported in the adverse events module. | Baseline, Posttest, Follow-Up Session at One-Week |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Function Decline as Measured by Number of Participants | Measured by the Box and Blocks Test and Grip Strength | Baseline, Posttest, Follow-Up Session at One-Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernadette Gillick, PhD, MS, PT | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25413621 | Result | Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20. |
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If a child did not exhibit a motor evoked potential from the ipsilesional cortex, they were excluded from the trial after enrollment but before assignment to a group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation | Receiving active tDCS tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
| FG001 | Sham tDCS | tDCS equipment set to placebo setting. tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pilot study estimating a sample of children with hemiparesis. No formal sample size nor power analysis was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation | Receiving active tDCS tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
| BG001 | Sham tDCS | tDCS equipment set to placebo setting. tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Adverse Events/Safety Assessment. | Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:
Detailed adverse events are reported in the adverse events module. | Pilot study therefore no sample size analysis. Completed per protocol. | Posted | Number | Participants | Baseline, Posttest, Follow-Up Session at One-Week |
|
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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 | Transcranial Direct Current Stimulation | Receiving active tDCS tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Reports of tingling under the electrodes. Assessed verbally by participant feedback at scheduled intervals: pre/post and follow-up sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernadette Gillick | University of Minnesota | 612.626.6415 | brown029@umn.edu |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham tDCS | tDCS equipment set to placebo setting. tDCS: transcranial direct current stimulation- non-invasive brain stimulation |
|
|
| Secondary | Hand Function Decline as Measured by Number of Participants | Measured by the Box and Blocks Test and Grip Strength | Posted | Number | participants | Baseline, Posttest, Follow-Up Session at One-Week |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Sham tDCS | tDCS equipment set to placebo setting. tDCS: transcranial direct current stimulation- non-invasive brain stimulation | 0 | 6 | 4 | 6 |
|
| Burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sleepiness | Nervous system disorders | Non-systematic Assessment |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |