Recruiting

tDCS with Physiotherapy

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT05637957

Conditions

Acquired Brain Injury

Stroke

Traumatic Brain Injury

Hemiparesis

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

active transcranial direct current stimulation

sham transcranial direct current stimulation

Study Details

Brief summary:

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.

Conditions

Acquired Brain Injury

Stroke

Traumatic Brain Injury

Hemiparesis

Study ID

NCT05637957

Start date

Jun 1, 2022

Status verified date

Nov, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physiotherapy + Active tDCS

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

active comparator: Physiotherapy + Sham tDCS

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

Interventions

active transcranial direct current stimulation

Device: 20 minutes of up to 2.0 mA active anodal tDCS (anode positioned at C3/4, cathode positioned at Fp1/2 as per 10-20 electrode placement guidelines) Behavioral: Physiotherapy motor skills based physiotherapy intervention (representative of typical goal-focused intervention in the clinical ABI program at Holland Bloorview), 45 minutes in duration

sham transcranial direct current stimulation

Device: 1 minute of 1.0 mA anodal tDCS (anode positioned at C3/4, cathode positioned at Fp1/2 as per 10-20 electrode placement guidelines) and 19 minutes with unit turned off and electrodes remaining in place Behavioral: Physiotherapy motor skills based physiotherapy intervention (representative of typical goal-focused intervention in the clinical ABI program at Holland Bloorview), 45 minutes in duration

Primary outcome measure

  • Gross Motor Function Measure (GMFM-88) [ Time Frame: Change from baseline to reassessment (4-6 weeks) ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from baseline to reassessment (4-6 weeks) ]
  • Eligibility Rate [ Time Frame: Duration of study (approximately 2 years) ]
  • Enrollment Rate [ Time Frame: Duration of study (approximately 2 years) ]
  • Adherence Rate [ Time Frame: Duration of study (approximately 2 years) ]
  • Transcranial direct current stimulation tolerance [ Time Frame: Duration of study (approximately 2 years) ]

Central Contacts and Locations

Central contacts

Trina Mitchell, PhD

416-425-6220tmitchell@hollandbloorview.ca

Jennifer Ryan, PT, MSc

416-425-6220jryan@hollandbloorview.ca

Locations

Holland Bloorview Kids Rehabilitation Hospital

Recruiting

Toronto, Ontario, Canada, M4G1R8

Contacts

Trina Mitchell

tmitchell@hollandbloorview.ca

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Dec 6, 2022

Last verified

Nov, 2022

Keywords

  • transcranial direct current stimulation
  • physiotherapy
  • pediatric
  • motor learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2022-12-06.