tDCS + Physiotherapy for Acquired Brain Injury

Overseen By Trina Mitchell, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Must not be taking: Botox, others

Disqualifiers: Seizures, Brain tumour, Neurodegenerative, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 5 weeks

10 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Virginia Wright, PhD

Principal Investigator

Clinician Scientist

Deryk Beal, PhD

Principal Investigator

Clinician Scientist

Are You a Good Fit for This Trial?

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

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.

I can handle 45 minutes of physical therapy.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The 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.

How Is the Trial Designed?

Group I: Physiotherapy + Active tDCS Experimental Treatment 1 Intervention

20 minutes of active anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions.

Group II: Physiotherapy + Sham tDCS Active Control 1 Intervention

20 minutes of sham anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions.

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+