10 Participants Needed

tDCS + Physiotherapy for Acquired Brain Injury

JR
TM
Overseen ByTrina Mitchell, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

DB

Deryk Beal, PhD

Principal Investigator

Clinician Scientist

VW

Virginia Wright, PhD

Principal Investigator

Clinician Scientist

Eligibility Criteria

This trial is for children aged 5-18 with acquired brain injuries like stroke or severe traumatic brain injury. They must be able to stand, walk at least 10m, and follow directions in English. Kids who've had recent Botox injections, seizures, metal implants in the head, or are on certain medications can't join.

Inclusion Criteria

Parent/legal guardian can read and speak English
I can handle 2 hours of physical therapy with short breaks.
I have weakness or paralysis on one side of my body, affecting my ankle movement.
See 13 more

Exclusion Criteria

I have not had Botox injections in the last 3 months.
I have stitches or staples on my head.
I am not planning any medication changes that would affect my participation in the study.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Baseline assessments conducted by a blinded independent PT assessor

2 weeks
1 visit (in-person)

Treatment

Participants receive active or sham tDCS immediately prior to physiotherapy sessions, twice weekly for 5 weeks

5 weeks
10 visits (in-person)

Follow-up

Participants are reassessed for gross motor function and other outcomes

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • tDCS
Trial OverviewThe study tests if adding transcranial direct current stimulation (tDCS) to regular physiotherapy helps improve motor skills in kids with brain injuries. Participants will get either real tDCS or a sham treatment before their therapy sessions twice a week for five weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Physiotherapy + Active tDCSExperimental Treatment1 Intervention
20 minutes of active anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions.
Group II: Physiotherapy + Sham tDCSActive Control1 Intervention
20 minutes of sham anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials
69
Recruited
14,100+