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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
Burke Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring Robotics, Upper Extremity

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 30, 2017
Last Updated
October 2, 2022
Sponsor
Burke Medical Research Institute
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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

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tDCS and Robotic Training in Adults With Cerebral Palsy

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