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 trial explores whether adding transcranial direct current stimulation (tDCS), a gentle brain-stimulation technique, to regular physiotherapy can help children and teens improve motor skills after a brain injury, such as a stroke or traumatic brain injury. Participants will receive either real or sham tDCS before their physiotherapy sessions to determine if the real treatment makes a difference. Ideal candidates are children and teens who have experienced a childhood stroke or moderate to severe traumatic brain injury, can walk at least 10 meters, and stand unaided for 10 seconds. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance recovery options for young patients.

What prior data suggests that this protocol is safe for children with acquired brain injury?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with brain injuries. Studies found that patients with severe traumatic brain injuries tolerated a single session of tDCS well. In children, the treatment is also considered safe when used during attention training over ten days.

For adults with long-term brain injuries, previous studies found tDCS to be both safe and effective. While most research has focused on adults, the results in children are encouraging and suggest that tDCS could be a good option. Overall, these studies indicate that tDCS is a well-tolerated treatment with few safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining transcranial direct current stimulation (tDCS) with physiotherapy for acquired brain injury because it offers a new way to enhance recovery. Unlike typical rehabilitation therapies that primarily focus on physical exercises and activities, tDCS uses a mild electrical current to stimulate specific brain areas, potentially boosting the brain's ability to repair and reorganize itself. This approach is promising because it may improve the effectiveness of physiotherapy sessions by priming the brain for better learning and adaptation. Additionally, because tDCS is non-invasive and relatively easy to administer, it could become a convenient addition to existing rehabilitation programs.

What evidence suggests that tDCS is effective for acquired brain injury?

This trial will compare the effects of active transcranial direct current stimulation (tDCS) with sham tDCS, both combined with physiotherapy, on movement and thinking skills in children with brain damage. Research has shown that tDCS may improve these skills, as studies have found it can aid in recovering motor skills after a brain injury. Previous research demonstrated that tDCS is safe and effective for adults with brain injuries, and early results are promising for children as well. Although more research is needed, initial findings suggest that tDCS could enhance physical abilities when used alongside physiotherapy. ^{5 6 7 8 9}

Who Is on the Research Team?

Deryk Beal, PhD

Principal Investigator

Clinician Scientist

Virginia Wright, 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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0887899425001717

The Effect of a Single Session of Transcranial Direct ... A single tDCS session targeting dlPFC or IFG did not improve attention following pediatric ABI. We demonstrated how HD-EEG source-based connectivity may be used ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943239/

Effect of Transcranial Direct Current Stimulation on Memory ... Results: Significant improvements in emotional states were observed post-tDCS. Hedonic tone increased (AIS: 2.5 to 5 stens; TBI: 1.5 to 4 stens) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03618849

NCT03618849 | tDCS in Pediatric Acquired Brain Injury Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11390413/

Effect of non-invasive brain stimulation in children with ... These studies examined the use of NIBS to manage motor disorders, hearing, vision, headaches, speech and language and memory issues.

5. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2025.2496783?af=R

Effects of transcranial direct current stimulation on motor ... tDCS seems beneficial in motor and cognitive functions in paediatric brain damage. Motor and cognitive functions appears to be interconnected, so combined ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190726/

Safety, Feasibility, and Tolerability of Ten Days of At-Home ... We demonstrated that 10 days of home-based, remotely supervised tDCS during attention training can be safe, feasible, and tolerable in children with acquired ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666459324000088

The safety and feasibility of transcranial direct current ... Our phase I safety study indicated that a single course of tDCS was safe in patients with severe traumatic brain injury.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03618849

NCT03618849 | tDCS in Pediatric Acquired Brain Injury Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10344463/

Safety and therapeutic effects of personalized transcranial ... Transcranial direct current stimulation (tDCS) has shown great potential for promoting neuro-electrochemical activity. However, previous tDCS studies did not ...