Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single-session tDCS in Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635775
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration produces changes in brain excitability and motor function. Participants with UCP, ages 7-21 years, will be assigned to one of four tDCS groups. Using single-pulse transcranial magnetic stimulation, the investigators will assess cortical excitability before and at regular intervals up to 1 hour following tDCS. The knowledge gained from this study will advance the field through more targeted approaches of neuromodulatory techniques in this population and others, using individual characteristics to guide optimal treatment

Condition or disease Intervention/treatment Phase
Cerebral Palsy Perinatal Stroke Periventricular Leukomalacia Device: Active tDCS Device: Sham tDCS Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and families will be masked to intervention group. The research team members performing assessments will be masked to intervention group.
Primary Purpose: Basic Science
Official Title: Effects of Single-session Transcranial Direct Current Stimulation in Children With Cerebral Palsy
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anodal ipsilesional Active tDCS
Anodal tDCS (excitatory) applied to the lesioned hemisphere. Participant must have lesioned hemisphere MEP.
Device: Active tDCS
Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.
Other Name: transcranial direct current stimulation

Experimental: Cathodal contralesional Active tDCS
Cathodal tDCS (inhibitory) applied to the non-lesioned hemisphere. Participant must have lesioned hemisphere MEP.
Device: Active tDCS
Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.
Other Name: transcranial direct current stimulation

Experimental: Anodal contralesional Active tDCS
Anodal tDCS (excitatory) applied to the non-lesioned hemisphere. Participant must not have lesioned hemisphere MEP.
Device: Active tDCS
Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.
Other Name: transcranial direct current stimulation

Sham Comparator: Sham tDCS
Sham tDCS applied in one of the above configurations
Device: Sham tDCS
Sham-setting--no electrical current delivered.




Primary Outcome Measures :
  1. Change in MEP amplitude [ Time Frame: Pre and Post-test (immediately after tDCS) ]
    Measure of cortical excitability using TMS


Secondary Outcome Measures :
  1. Change in Movement accuracy [ Time Frame: Pre and Post-test (60 minutes after tDCS) ]
    Accuracy during finger tracking task



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (for all participants):

  • Ages 7-21
  • Able to follow two-step commands.
  • Presence of an MEP in the non-lesioned hemisphere

Exclusion Criteria (for all participants):

  • Evidence of seizure within 2 years
  • Other neurological or metabolic conditions
  • Is pregnant (females only)
  • Presence of indwelling metal in the head (e.g. aneurysm clip) or medical device.

Inclusion Criteria (for participants with cerebral palsy):

  • Clinical diagnosis of unilateral cerebral palsy
  • Radiological evidence of stroke or periventricular leukomalacia

Exclusion Criteria(for participants with cerebral palsy):

  • Treatment with injectable agents (e.g. Botox) for spasticity management within 2 months

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): NCT03635775


Contacts
Layout table for location contacts
Contact: Samuel T Nemanich, PhD 6125972163 nemanich@umn.edu
Contact: Maureen Boxrud 6126266415 brown029@umn.edu

Locations
Layout table for location information
United States, Minnesota
Samuel Nemanich Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Samuel Nemanich, PhD    6126260637    nemanich@umn.edu   
Contact: Maureen Boxrud    6126266415    brown029@umn.edu   
Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:
Informed Consent Form  [PDF] April 30, 2018


Publications:

Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03635775     History of Changes
Other Study ID Numbers: STUDY00002820
P2CHD086844 ( U.S. NIH Grant/Contract )
K01HD078484 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
non-invasive brain stimulation
rehabilitation
pediatrics
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Leukomalacia, Periventricular
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases