tDCS and Robotic Training in Adults With Cerebral Palsy

October 2, 2022 updated by: Kathleen Friel, Burke Medical Research Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10605
        • Burke Medical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burke Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC 467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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