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Trial record 71 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

tDCS and Robotic Training in Adults With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03038269
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kathleen Friel, Burke Medical Research Institute

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Hemiplegia Behavioral: Upper Extremity Robotics, tDCS Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Fugl-Meyer Assessment of Motor Recovery [ Time Frame: 1 Week ]
    Evaluates and measures recovery


Secondary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 1 Week ]
    Quantifies upper extremity motor ability through timed and functional tasks

  2. Box and Blocks Test [ Time Frame: 1 Week ]
    Measures unilateral gross motor dexterity.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038269


Contacts
Contact: Kathleen Friel, PhD 914-368-3116 braininjuryclinic@med.cornell.edu
Contact: Zoe Tsagaris, MS 914-597-2153 kzt3001@med.cornell.edu

Locations
United States, New York
Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Kathleen Friel, PhD    914-368-3116    braininjuryclinic@med.cornell.edu   
Sponsors and Collaborators
Burke Medical Research Institute

Responsible Party: Kathleen Friel, Director, Clinical Laboratory for Early Brain Injury Recovery, Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03038269     History of Changes
Other Study ID Numbers: BRC 467
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kathleen Friel, Burke Medical Research Institute:
Robotics
Upper Extremity

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms