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

NCT05637957 | Unknown DMC

• 1 other identifier: 504
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial direct current stimulation; physiotherapy; pediatric; motor learning

Outcome Measures

Primary Outcomes (6)

• Gross Motor Function Measure (GMFM-88)

  A standardized physiotherapy assessment (validated for children with ABI) that assesses gross motor function in five dimensions (A- lying \& rolling, B- sitting, C- crawling \& kneeling, D- standing, walking, E-running \& jumping). Each of the 88 items is scored from 0-3.

  Change from baseline to reassessment (4-6 weeks)

• Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure is a standardized outcome measure that allows children and families to set goals and evaluate their performance and satisfaction with each goal on a scale of 1 to 10, where higher ratings mean increased performance and satisfaction. In this study, the goals will be participation-based goals related to gross motor activities.

  Change from baseline to reassessment (4-6 weeks)

• Eligibility Rate

  The proportion of eligible participants compared to the number of children identified by brain injury clinicians using preliminary screening checklist.

  Duration of study (approximately 2 years)

• Enrollment Rate

  The proportion of eligible participants who enrollment in the study.

  Duration of study (approximately 2 years)

• Adherence Rate

  Proportion of participants who completed 10 treatment sessions

  Duration of study (approximately 2 years)

• Transcranial direct current stimulation tolerance

  The proportion of tDCS sessions that were started lasting the entire treatment session

  Duration of study (approximately 2 years)

Secondary Outcomes (4)

• Acquired Brain Injury Challenge Assessment (ABI-CA)

  Change from baseline to reassessment (4-6 weeks)

• 10m Fast Walk Test

  Change from baseline to reassessment (4-6 weeks)

• Goal Attainment Scaling

  Change from baseline to reassessment (4-6 weeks)

• Pediatric Evaluation of Disability Inventory (Mobility and Self-Care domains)

  Change from baseline to reassessment (4-6 weeks)

Study Arms (2)

Physiotherapy + Active tDCS

EXPERIMENTAL

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

Device: active transcranial direct current stimulation

Physiotherapy + Sham tDCS

ACTIVE COMPARATOR

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

Device: sham transcranial direct current stimulation

Interventions

active transcranial direct current stimulation DEVICE

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

Physiotherapy + Active tDCS

sham transcranial direct current stimulation DEVICE

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

Physiotherapy + Sham tDCS

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Stroke or moderate to severe traumatic brain injury, diagnosed with imaging (e.g., MRI, CT scan);
• 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

You may not qualify if:

• 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.…);

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic; Paresis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deryk Beal, PhD

  Clinician Scientist

  PRINCIPAL INVESTIGATOR

• Virginia Wright, PhD

  Clinician Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trina Mitchell, PhD

CONTACT

416-425-6220; tmitchell@hollandbloorview.ca

Jennifer Ryan, PT, MSc

CONTACT

416-425-6220; jryan@hollandbloorview.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Physiotherapists providing treatment, physiotherapists conducting assessment, research coordinator, principal investigators, participants are all blinded to treatment allocation. Research assistants administered the transcranial direct current stimulation are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomized feasibility trial

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 6, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)