Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04422886 |
Other study ID # |
19-857 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 15, 2020 |
Est. completion date |
September 30, 2021 |
Study information
Verified date |
November 2022 |
Source |
Holland Bloorview Kids Rehabilitation Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives
The purpose of this study is to test the feasibility of using tDCS as a pre-treatment adjunct
to intensive physiotherapy (the 'physio+tDCS' protocol) for children with ABI in the
inpatient brain injury program at Holland Bloorview. The primary objectives of our study are
to answer the following questions:
1. Is it feasible to implement a 'physio+tDCS' protocol within an existing inpatient ABI
rehabilitation program based on participant eligibility, recruitment, tolerance,
retention, and adherence to treatment protocol (e.g. session frequency and completion
timelines)?
2. What is the effect of using tDCS as an adjunct to intensive physiotherapy on the
recovery of gross motor function in children with moderate to severe ABI, as measured by
individualized goal achievement and standardized gross motor outcome measures? METHODS
Trial design Using a feasibility randomized control trial (RCT) study design, 30
children with moderate to severe ABI, enrolled in intensive brain injury rehabilitation
at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, will be randomized
to the active or sham (control) tDCS intervention, which will be paired with
individualized intensive physiotherapy (i.e., 'physio+tDCS' and 'physio+sham').
Randomization and Blinding Once enrolled in the study, an independent research assistant (RA)
will randomly assign each child to the "sham" or "active" tDCS treatment group using a
computer randomization web-based program and approach described below. Only the RAs involved
in the study will be aware of each participant's treatment group assignment. The participants
and the assessing/treating PTs will be blinded to the participant's treatment group.
Intervention tDCS Treatment- Depending on treatment group allocation, participants will
receive 20 minutes of active tDCS or sham tDCS (provided by a trained RA) immediately prior
to four of their physiotherapy sessions each week over 4 weeks for a total of 16 sessions.
Children and PTs will be blinded to their tDCS/sham allocation. Two electrodes (5x7cm) in
size will be used such that the anodal electrode will be attached to the Cz position on the
scalp, to target the lower extremity region of bilateral primary motor cortices, and the
cathodal electrode will be attached to the central supraorbital (Fpz) area of the forehead
(20). Each tDCS treatment will consist of up to 2.0 mA of stimulation, adjusting for the
child's age, head size, and tolerance as required. Participants will be told which treatment
group they were allocated to after completing their final assessment (3 months after
completing the treatment protocol). Participant symptoms and safety will be tracked before,
during, and after each tDCS session. Adverse events reported via a REB-approved standard
process to an independent in-house safety monitoring committee (SMC).
Physiotherapy Intervention- The physiotherapy treatment paired with the tDCS/sham consists of
the typical motor skills-based physiotherapy children receive in the in/day-patient brain
injury program at Holland Bloorview. Each 45- minute physiotherapy session promotes motor
learning by focusing on functional tasks related to the child's personalized motor goals.
Therapists individualize the program by adapting the tasks, instructions, feedback, and the
level of challenge based on the child's needs.
Outcomes Feasibility- Feasibility of study implementation and tDCS will be evaluated by
tracking process, resource, and treatment indicators. A priori feasibility targets are as
follows: 20% of children admitted to the program will be eligible for the study, 70% of
eligible children will be recruited; 80% of children will tolerate at least 1.0mA for 10
minutes of each tDCS session, 75% of treatment sessions will be completed, 95% of first
reassessments will occur, and 80% of follow-up reassessments will occur at 3 months
post-treatment. Adherence to the study protocol will be tracked by the number of tDCS and
physiotherapy sessions scheduled per week and the number actually completed. Reasons for
cancelled sessions or decreased number of sessions booked will be documented. Because tDCS
should optimally occur in the half hour prior to physiotherapy, the start time and duration
of stimulation will be documented, as well as the start time and duration of each
physiotherapy session, on tracking sheets that will be completed by the RA/therapist
conducting each tDCS/physiotherapy session. Eligibility data will be tracked across the
study's duration to determine the proportion of children in the brain injury program who are
eligible for the study, and the number who enrol and reasons for being excluded from the
study will be documented.
Gross Motor- Baseline assessments will be conducted by a blinded independent PT assessor
within four days of beginning the study treatment protocol. The first reassessment will be
conducted by the same blinded PT assessor within four days after their last study
intervention session. Three months after completion of the study treatment, a second
reassessment will take place, involving the same outcome measures. Additional information
regarding the participant's physiotherapy services (e.g., frequency, duration, focus of
intervention) and amount of daily physical activity (e.g., frequency, duration, intensity,
type) since study completion will also be recorded.
A priori targets for the co-primary gross motor outcomes are as follows: The active tDCS
group should have at least 5 mean points of change more than the sham group on the Gross
Motor Function Measure (GMFM) and at least 2.0 mean points of change more than the sham group
on the Canadian Occupational Performance Measure (COPM).