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

Launched by HOLLAND BLOORVIEW KIDS REHABILITATION HOSPITAL · Nov 25, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called transcranial direct current stimulation (tDCS) can help improve motor skills in children and youth who have experienced an acquired brain injury, such as a stroke or traumatic brain injury. The study will involve up to 10 children, aged 5 to 18 years, who will receive either the active tDCS treatment or a placebo (sham) treatment right before their physiotherapy sessions. Participants will attend these sessions twice a week for five weeks, and their progress will be measured before and after the treatment to see if tDCS makes a difference in their motor skills.

To be eligible for the trial, children must have had a stroke or moderate to severe traumatic brain injury, be in an outpatient rehabilitation stage, and be able to walk at least 10 meters with or without help. They should also be medically stable and able to attend appointments consistently. Throughout the study, participants will undergo physiotherapy sessions and assessments, and their families will be informed about any specific requirements or procedures. This research aims to understand if combining tDCS with physiotherapy can be a helpful approach for improving recovery in these young patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Stroke or moderate to severe traumatic brain injury, diagnosed with imaging (e.g., MRI, CT scan);
• • 5-18 years of age inclusive (at time of study enrolment);
• • In the outpatient stage of rehabilitiation
• • Followed by a physician through ABI medical follow-up clinic at Holland Bloorview OR previously admitted to the inpatient ABI program at Holland Bloorview;
• • Medically stable, as determined by their ABI physician;
• • Walks a minimum of 10m with or without assistance;
• • Stands independently for 10s;
• • Balances for less than 20s on most affected leg;
• • 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);
• • Available to attend twice weekly appointments for five weeks, as well as a two-hour baseline and post-treatment assessment;
• • Tolerates 2 hours of physiotherapy assessment (with short breaks as needed);
• • Tolerates 45 minutes of physiotherapy treatment;
• • Capable of participating in standardized physiotherapy assessment, from a cognitive and behavioural perspective; and
• • Can communicate discomfort either verbally or non-verbally
• • Follows directions provided in English
• • Parent/legal guardian can read and speak English
• Exclusion Criteria:
• • Admitted to acute care or inpatient rehabilitation hospital
• • Seizure(s) in the last 6 months;
• • Planned medication changes during study (i.e., any medication that affects their ability to participate in therapy from a physical, cognitive, emotional standpoint);
• • Botox injections in the last 3 months;
• • Brain tumour;
• • Metal implants or fragments in the head;
• • Cranial bone flap removed;
• • Stitches/staples on the head;
• • Wounds or unhealed incisions at electrode placement sites;
• • Cochlear implant;
• • Implanted neurostimulator (e.g., vagal nerve stimulator, deep brain stimulator);
• • Cardiac pacemaker;
• • Battery-powered medication infusion device (e.g., baclofen or insulin pump);
• • Pregnancy;
• • Diagnosed with another neuromotor disorder(s) affecting gross motor function (e.g., cerebral palsy, spinal cord injury, etc....);
• • Onset of ABI before the age of two years;
• • Neurodegenerative diagnosis;
• • Lower extremity weight bearing activity restrictions secondary to injuries (e.g., fracture, ligamentous injury) as present at time of study enrollment;
• • Non-orthopaedic activity restrictions that limit gross motor activity (e.g., splenic laceration with orders not to run or jump); or
• • Enrolment in another treatment-based research study during the current study

Trial Officials