Feasibility of tDCS as an Adjunct to Outpatient Physiotherapy in Children With ABI

Stroke Clinical Trial

Official title: The Feasibility of Transcranial Direct Current Stimulation as an Adjunct to Outpatient Physiotherapy in Children With Acquired Brain Injury

Status Recruiting

Clinical Trial Summary

This study will evaluate the feasibility of transcranial direct current stimulation (tDCS) as an adjunct to an outpatient motor skills-based physiotherapy intervention for children and youth with acquired brain injury. Up to 10 children (age 5-18 years) with childhood onset stroke or traumatic brain injury will be randomly allocated to receive active or sham anodal tDCS immediately prior to the physiotherapy session. These sessions will occur twice weekly for a total of 10 sessions. Assessment of gross motor outcome measures will occur immediately before and after the combined tDCS and physiotherapy treatment protocol. The preliminary treatment effect between the two treatment groups will be compared and other feasibility indicators will be evaluated.

Clinical Trial Description

Objectives: The purpose of this study is to evaluate the feasibility of tDCS as a pre-treatment adjunct to outpatient physiotherapy (our outpatient 'physio+tDCS' protocol) for children with stroke or TBI. The primary objective is to evaluate the feasibility of an outpatient twice weekly 'physio+tDCS' protocol given over five weeks, as measured by participant eligibility, recruitment, tolerance, retention, and adherence to treatment protocol (e.g., session frequency and completion timelines). The secondary objective is to explore the preliminary effect of physio+tDCS on gross motor function in children with childhood onset stroke and TBI, as measured by individualized goal achievement and standardized gross motor outcome measures.

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. 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 two physiotherapy sessions each week for a total of 10 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 C3/4 position on the scalp, to target the lower extremity region of the primary motor cortex most affected by their brain injury, and the cathodal electrode will be attached to the contralateral supraorbital (Fp1/Fp2) area of the forehead. 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. 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. Physiotherapy Intervention- The physiotherapy treatment paired with the tDCS consists of the typical motor skills-based physiotherapy children receive 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: 30% of children indentified by the child's clinical physiotherapist or nurse will be eligible for the study, 70% of eligible children will be recruited; 80% of the tDCS sessions started will last the entire 20-minute duration, 75% of treatment sessions will be completed, and 90% of reassessments will occur in the 14 days following the final treatment session. 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.

Gross Motor- Baseline assessments will be conducted by a blinded independent PT assessor in the two weeks prior to beginning the study treatment protocol. The reassessment will be conducted by the same blinded PT assessor up to two weeks after their last study intervention session. A priori targets for the co-primary gross motor outcomes are as follows: The active tDCS group should have at least 3 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). ;

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Hemiparesis
• Paresis
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT05637957
• Study type: Interventional
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Trina Mitchell, PhD
• Phone: 416-425-6220
• Email: tmitchell@hollandbloorview.ca
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Completion date: December 31, 2024