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Does Physiotherapy Plus Non-invasive Brain Stimulation Improve Motor Recovery in Children With Acquired Brain Injury?

NCT04422886 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-11-30

No results posted yet for this study

Summary

The current study will evaluate the feasibility of transcranial direct current stimulation (tDCS) combined with an existing intensive physiotherapy program for children with ABI within the in/day-patient brain injury program at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. This feasibility randomized control trial will allocate 30 participants with ABI (age 5 to 18 years) to one of two treatment groups. One group will receive active tDCS prior to four of their existing physiotherapy sessions each week for a total of 16 sessions while the other group will receive sham/placebo tDCS prior to their physiotherapy sessions. Recovery of gross motor function will be compared between groups after the four weeks of tDCS treatment and again after three months to evaluate the short and longer-term impact of tDCS on an existing intensive physiotherapy program. Feasibility will be evaluated by tracking process, resource, and treatment indicators such as eligibility, enrollment, adherence, and tolerance rates.

Conditions

  • Acquired Brain Injury
  • Recovery of Function
  • Transcranial Electrical Stimulation

Interventions

DEVICE

active transcranial direct current stimulation (tDCS)

20 minutes at 2.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines)

BEHAVIORAL

Physiotherapy

motor skills based physiotherapy intervention (representative of typical goal-focused intervention in the clinical ABI program at Holland Bloorview), 45 minutes in duration

DEVICE

sham transcranial direct current stimulation (sham)

1 minutes at 1.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines) and 19 minutes with unit shut off and electrodes remaining on the scalp

Sponsors & Collaborators

  • Holland Bloorview Kids Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Deryk S Beal, PhD · Clinician Scientist

  • Virginia Wright, PhD · Clinican Scientist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422886 on ClinicalTrials.gov