Brain Stimulation and Hand Training in Children With Hemiparesis
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: tDCS/CIMT Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
Device: Transcranial Direct Current Stimulation (tDCS)
10 tDCS/CIMT Sessions
Other Names:
|
| Placebo Comparator: tDCS sham/CIMT Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
Device: Placebo Comparator
|
Outcome Measures
Primary Outcome Measures
- Change in Assisting Hand Assessment (AHA) [2 weeks, 6 months]
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.
Secondary Outcome Measures
- Change in Canadian Occupational Performance Measurement (COPM) [2 weeks, 6 months]
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.
Other Outcome Measures
- Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months [2 weeks, 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
-
≥ 10 degrees of active motion at the metacarpophalangeal joint
-
Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
-
No evidence of seizure activity within the last 2 years
-
Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
-
Ages 8-21 years
-
Able to give informed assent along with the informed consent of the legal guardian
-
Children who have had surgeries, which may influence motor function eg- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.
Exclusion Criteria:
-
Metabolic Disorders
-
Neoplasm
-
Epilepsy
-
Disorders of Cellular Migration and Proliferation
-
Acquired Traumatic Brain Injury
-
Pregnancy
-
Indwelling metal or incompatible medical devices
-
Evidence of skin disease or skin abnormalities
-
Botulinum toxin or Phenol block within [six-months] preceding the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 2 | Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | United States | 55101 |
Sponsors and Collaborators
- University of Minnesota
- Cerebral Palsy International Research Foundation
- Foundation for Physical Therapy, Inc.
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT, University of Minnesota
Study Documents (Full-Text)
More Information
Publications
- 1408M53169
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT |
|---|---|---|
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 10 | 10 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator | Total of all reporting groups |
| Overall Participants | 10 | 10 | 20 |
| Age (Count of Participants) | |||
| <=18 years |
10
100%
|
8
80%
|
18
90%
|
| Between 18 and 65 years |
0
0%
|
2
20%
|
2
10%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Median (Standard Deviation) ] | |||
| Median (Standard Deviation) [years] |
12.33
(3.08)
|
13.17
(5.08)
|
12.7
(4.17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
50%
|
6
60%
|
11
55%
|
| Male |
5
50%
|
4
40%
|
9
45%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
10
100%
|
10
50%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
8
80%
|
0
0%
|
8
40%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
20%
|
0
0%
|
2
10%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
10
100%
|
20
100%
|
Outcome Measures
| Title | Change in Assisting Hand Assessment (AHA) |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT |
|---|---|---|
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
| Measure Participants | 10 | 10 |
| 2 weeks |
6.4
|
8
|
| 6 months |
5.5
|
7.6
|
| Title | Change in Canadian Occupational Performance Measurement (COPM) |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT |
|---|---|---|
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
| Measure Participants | 10 | 10 |
| 2 weeks |
2.14
|
1.8
|
| 6 months |
2.94
|
3.22
|
| Title | Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT |
|---|---|---|
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator |
| Measure Participants | 10 | 10 |
| Mean (95% Confidence Interval) [score on a scale] |
1.7
|
1.76
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | tDCS/CIMT | tDCS Sham/CIMT | ||
| Arm/Group Description | 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 | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Placebo Comparator | ||
All Cause Mortality |
||||
| tDCS/CIMT | tDCS Sham/CIMT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| tDCS/CIMT | tDCS Sham/CIMT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| tDCS/CIMT | tDCS Sham/CIMT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | 10/10 (100%) | ||
| General disorders | ||||
| Headache | 4/10 (40%) | 9 | 1/10 (10%) | 1 |
| Unusual Feelings on the Skin of the Head | 2/10 (20%) | 5 | 1/10 (10%) | 1 |
| Itchiness | 1/10 (10%) | 5 | 3/10 (30%) | 6 |
| Unusual Feelings or Emotions | 1/10 (10%) | 2 | 0/10 (0%) | 0 |
| Dizziness | 0/10 (0%) | 0 | 3/10 (30%) | 3 |
| Nausea | 0/10 (0%) | 0 | 1/10 (10%) | 1 |
| Tingling | 2/10 (20%) | 10 | 2/10 (20%) | 2 |
| Difficulty Paying Attention | 0/10 (0%) | 0 | 1/10 (10%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Bernadette Gillick |
|---|---|
| Organization | University of Minnesota |
| Phone | 612-626-6415 |
| gillick@umn.edu |
- 1408M53169