Hemiparesis
Conditions
Brief summary
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: 1. tDCS will not produce a major adverse event, including seizure activity. 2. No change in paretic or nonparetic hand function or cognitive status will occur.
Detailed description
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.
Interventions
DEVICEtDCS
transcranial direct current stimulation- non-invasive brain stimulation
Sponsors
Minnesota Medical Foundation
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report. 2. Hemispheric Stroke or Periventricular Leukomalacia 3. Ages 8-17 years old 4. ≥ 10 degrees of active motion at the metacarpophalangeal joint 5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence 6. No evidence of seizure activity within the last 2 years. 7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.
Exclusion criteria
1. Metabolic Disorders 2. Neoplasm 3. Epilepsy 4. Disorders of Cellular Migration and Proliferation 5. Acquired Traumatic Brain Injury 6. Expressive Aphasia 7. Pregnancy 8. Indwelling metal or incompatible medical devices 9. Evidence of skin disease or skin abnormalities 10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events/Safety Assessment. | Baseline, Posttest, Follow-Up Session at One-Week | 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: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Function Decline as Measured by Number of Participants | Baseline, Posttest, Follow-Up Session at One-Week | Measured by the Box and Blocks Test and Grip Strength |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation Receiving active tDCS
tDCS: transcranial direct current stimulation- non-invasive brain stimulation | 5 |
| Sham tDCS tDCS equipment set to placebo setting.
tDCS: transcranial direct current stimulation- non-invasive brain stimulation | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | Sham tDCS | Transcranial Direct Current Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 16.9 years STANDARD_DEVIATION 2.6 | 10.7 years STANDARD_DEVIATION 3.2 | 14.7 years STANDARD_DEVIATION 3.5 |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 4 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
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: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.
Time frame: Baseline, Posttest, Follow-Up Session at One-Week
Population: Pilot study therefore no sample size analysis. Completed per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Adverse Events/Safety Assessment. | Any Change in Vital Signs | 0 Participants |
| Transcranial Direct Current Stimulation | Adverse Events/Safety Assessment. | Decline in Physician Evaluation | 0 Participants |
| Transcranial Direct Current Stimulation | Adverse Events/Safety Assessment. | Reported Serious Adverse Events | 0 Participants |
| Sham tDCS | Adverse Events/Safety Assessment. | Any Change in Vital Signs | 0 Participants |
| Sham tDCS | Adverse Events/Safety Assessment. | Decline in Physician Evaluation | 0 Participants |
| Sham tDCS | Adverse Events/Safety Assessment. | Reported Serious Adverse Events | 0 Participants |
Secondary
Hand Function Decline as Measured by Number of Participants
Measured by the Box and Blocks Test and Grip Strength
Time frame: Baseline, Posttest, Follow-Up Session at One-Week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transcranial Direct Current Stimulation | Hand Function Decline as Measured by Number of Participants | 0 participants |
| Sham tDCS | Hand Function Decline as Measured by Number of Participants | 0 participants |