tDCS and Robotic Training in Adults With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Hemiplegia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Upper Extremity Robotics, tDCS
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring Robotics, Upper Extremity
Eligibility Criteria
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
Sites / Locations
- Burke Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham tDCS
Active tDCS
Arm Description
Participant will receive a placebo-type stimulation followed by upper extremity robotic training.
Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment of Motor Recovery
Evaluates and measures recovery
Secondary Outcome Measures
Wolf Motor Function Test
Quantifies upper extremity motor ability through timed and functional tasks
Box and Blocks Test
Measures unilateral gross motor dexterity.
Full Information
NCT ID
NCT03038269
First Posted
January 30, 2017
Last Updated
October 2, 2022
Sponsor
Burke Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03038269
Brief Title
tDCS and Robotic Training in Adults With Cerebral Palsy
Official Title
Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burke Medical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia
Keywords
Robotics, Upper Extremity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Participant will receive a placebo-type stimulation followed by upper extremity robotic training.
Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.
Intervention Type
Behavioral
Intervention Name(s)
Upper Extremity Robotics, tDCS
Intervention Description
Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Motor Recovery
Description
Evaluates and measures recovery
Time Frame
1 Week
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Quantifies upper extremity motor ability through timed and functional tasks
Time Frame
1 Week
Title
Box and Blocks Test
Description
Measures unilateral gross motor dexterity.
Time Frame
1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Burke Medical Research Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28505986
Citation
Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.
Results Reference
result
Learn more about this trial
tDCS and Robotic Training in Adults With Cerebral Palsy
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