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| Name | Class |
|---|---|
| Cerebral Palsy International Research Foundation | OTHER |
| Foundation for Physical Therapy, Inc. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain.
Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques.
Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery.
Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability.
To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)
We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS/CIMT | Active Comparator | Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
|
| tDCS sham/CIMT | Placebo Comparator | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | 10 tDCS/CIMT Sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Assisting Hand Assessment (AHA) | Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. | 2 weeks, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Canadian Occupational Performance Measurement (COPM) | The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the "average satisfaction score", ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months | The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernadette T Gillick, PhD, MSPT, PT | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Gillette Children's Specialty Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26558386 | Background | Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1. | |
| 30471965 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS/CIMT | Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions |
| FG001 | tDCS Sham/CIMT | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS/CIMT | Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions |
| BG001 | tDCS Sham/CIMT |
| 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 | Change in Assisting Hand Assessment (AHA) | Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks, 6 months |
|
6 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 | tDCS/CIMT | Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernadette Gillick | University of Minnesota | 612-626-6415 | gillick@umn.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 | May 9, 2017 | Jul 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D010291 | Paresis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Placebo Comparator | Device |
|
| 2 weeks, 6 months |
| 2 weeks, 6 months |
| Saint Paul |
| Minnesota |
| 55101 |
| United States |
| Lixandrao MC, Stinear JW, Rich T, Chen CY, Feyma T, Meekins GD, Gillick BT. EMG breakthrough during cortical silent period in congenital hemiparesis: a descriptive case series. Braz J Phys Ther. 2020 Jan-Feb;24(1):20-29. doi: 10.1016/j.bjpt.2018.11.002. Epub 2018 Nov 22. |
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
Placebo Comparator
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | tDCS Sham/CIMT | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
|
|
| Secondary | Change in Canadian Occupational Performance Measurement (COPM) | The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the "average satisfaction score", ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks, 6 months |
|
|
|
| Other Pre-specified | Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months | The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks, 6 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | tDCS Sham/CIMT | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator | 0 | 10 | 0 | 10 | 10 | 10 |
| Unusual Feelings on the Skin of the Head | General disorders | Systematic Assessment |
|
| Itchiness | General disorders | Systematic Assessment |
|
| Unusual Feelings or Emotions | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Tingling | General disorders | Systematic Assessment |
|
| Difficulty Paying Attention | General disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D013514 | Surgical Procedures, Operative |