tDCS and Robotic Training in Adults With Cerebral Palsy

Study Overview
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Brief Summary
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The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.

Detailed Description
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Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training. Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions). Before and after therapy, participants will receive and assessment of their arm function, as well as an assessment of their brain activity, using electroencephalography (EEG) and transcranial magnetic stimulation (TMS).

Official Title
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Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy

Conditions
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Cerebral Palsy, Hemiplegia

Intervention / Treatment
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* Behavioral: Upper Extremity Robotics, tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant willing and able to provide informed consent Diagnosis of hemiplegic Cerebral Palsy Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal interphalangeal joints (10 degrees) Exclusion Criteria: Cognitive deficits that impede understanding of study protocol Current medical illness unrelated to CP Visual problems (uncorrected by glasses/contact lenses) High motor ability in affected arm Severe spasticity Lack of asymmetry in hand function Orthopedic surgery in affected arm within 2 years Dorsal root rhizotomy Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period Currently receiving intrathecal baclofen Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, deices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator) True positive response on the Transcranial Magnetic Stimulation Safety Screen Current use of medications known to lower the seizure threshold Previous episode of neurocardiogenic snycopy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham tDCS<br>Participant will receive a placebo-type stimulation followed by upper extremity robotic training. | Behavioral: Upper Extremity Robotics, tDCS<br>* Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.<br>|
| Active Comparator: Active tDCS<br>Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training. | Behavioral: Upper Extremity Robotics, tDCS<br>* Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of Motor Recovery | Evaluates and measures recovery | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test | Quantifies upper extremity motor ability through timed and functional tasks | 1 Week | 
| Box and Blocks Test | Measures unilateral gross motor dexterity. | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotics, Upper Extremity