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tDCS + Physiotherapy for Acquired Brain Injury

N/A
Recruiting
Led By Virginia Wright, PhD
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemiplegia, identified by decreased selective motor control at one ankle compared to the other (i.e., decreased ability to isolate ankle plantar flexion and dorsiflexion on the more affected ankle)
Stroke or moderate to severe traumatic brain injury, diagnosed with imaging (e.g., MRI, CT scan)
Must not have
Stitches/staples on the head
Brain tumour
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (approximately 2 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate if using a mild electrical current can help children with brain injuries learn motor skills better in physiotherapy. Up to 10 kids (5-18yo) will get either active or sham treatment. Results will be compared.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of tDCS include mild discomfort at the electrode site on the head, itching under the electrodes during stimulation, a slight headache or fatigue after treatment. These are generally temporary and considered mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have weakness or paralysis on one side of my body, affecting my ankle movement.
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I have had a stroke or serious brain injury confirmed by a scan.
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I can't balance on my most affected leg for more than 20 seconds.
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I can walk at least 10 meters, with or without help.
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I am between 5 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have stitches or staples on my head.
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I have a brain tumor.
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I have had a part of my skull removed.
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I have open wounds or unhealed cuts where the device would be placed.
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I am currently in a hospital or rehab center.
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I have a condition like cerebral palsy affecting my movement.
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My ABI started before I turned two years old.
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I have metal implants or fragments in my head.
Select...
I have had a seizure in the past 6 months.
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I have been diagnosed with a neurodegenerative condition.
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I currently have an injury that limits my ability to put weight on my legs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence Rate
Canadian Occupational Performance Measure (COPM)
Eligibility Rate
+3 more
Secondary study objectives
10m Fast Walk Test
Acquired Brain Injury Challenge Assessment (ABI-CA)
Goal Attainment Scaling
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
67 Previous Clinical Trials
14,057 Total Patients Enrolled
3 Trials studying Stroke
152 Patients Enrolled for Stroke
Virginia Wright, PhDPrincipal InvestigatorClinician Scientist
2 Previous Clinical Trials
164 Total Patients Enrolled
Deryk Beal, PhDPrincipal InvestigatorClinician Scientist
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Physiotherapy + Active tDCS Clinical Trial Eligibility Overview. Trial Name: NCT05637957 — N/A
Stroke Research Study Groups: Physiotherapy + Active tDCS, Physiotherapy + Sham tDCS
Stroke Clinical Trial 2023: Physiotherapy + Active tDCS Highlights & Side Effects. Trial Name: NCT05637957 — N/A
Physiotherapy + Active tDCS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05637957 — N/A
~0 spots leftby Dec 2024
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