Acquired Brain InjuryNCT05637957
Feasibility of tDCS as an Adjunct to Outpatient Physiotherapy in Children With ABI
A study testing active transcranial direct current stimulation in people with Acquired Brain Injury and Stroke, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Acquired Brain Injury, Stroke, Traumatic Brain Injury
- What is being tested?
- active transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Show all 16Show fewer
- 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
Who cannot join
- 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;
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
Trina Mitchell, tmitchell@hollandbloorview.ca
About this study
Official title: The Feasibility of Transcranial Direct Current Stimulation as an Adjunct to Outpatient Physiotherapy in Children With Acquired Brain Injury
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.
Read the detailed description
Objectives: The purpose of this study is to evaluate the feasibility of tDCS as a pre-treatment adjunct to outpatient physiotherapy (our outpatient 'physio+tDCS' protocol) for children with stroke or TBI. The primary objective is to evaluate the feasibility of an outpatient twice weekly 'physio+tDCS' protocol given over five weeks, as measured by participant eligibility, recruitment, tolerance, retention, and adherence to treatment protocol (e.g., session frequency and completion timelines). The secondary objective is to explore the preliminary effect of physio+tDCS on gross motor function in children with childhood onset stroke and TBI, as measured by individualized goal achievement and standardized gross motor outcome measures.
Randomization and Blinding: Once enrolled in the study, an independent research assistant (RA) will randomly assign each child to the "sham" or "active" tDCS treatment group using a computer randomization web-based program. Only the RAs involved in the study will be aware of each participant's treatment group assignment. The participants and the assessing/treating PTs will be blinded to the participant's treatment group.
Intervention:
tDCS Treatment- Depending on treatment group allocation, participants will receive 20 minutes of active tDCS or sham tDCS (provided by a trained RA) immediately prior to two physiotherapy sessions each week for a total of 10 sessions. Children and PTs will be blinded to their tDCS/sham allocation. Two electrodes (5x7cm) in size will be used such that the anodal electrode will be attached to the C3/4 position on the scalp, to target the lower extremity region of the primary motor cortex most affected by their brain injury, and the cathodal electrode will be attached to the contralateral supraorbital (Fp1/Fp2) area of the forehead. Each tDCS treatment will consist of up to 2.0 mA of stimulation, adjusting for the child's age, head size, and tolerance as required. Participant symptoms and safety will be tracked before, during, and after each tDCS session. Adverse events reported via a REB-approved standard process to an independent in-house safety monitoring committee. Physiotherapy Intervention- The physiotherapy treatment paired with the tDCS consists of the typical motor skills-based physiotherapy children receive brain injury program at Holland Bloorview. Each 45-minute physiotherapy session promotes motor learning by focusing on functional tasks related to the child's personalized motor goals. Therapists individualize the program by adapting the tasks, instructions, feedback, and the level of challenge based on the child's needs.
Outcomes Feasibility- Feasibility of study implementation and tDCS will be evaluated by tracking process, resource, and treatment indicators. A priori feasibility targets are as follows: 30% of children indentified by the child's clinical physiotherapist or nurse will be eligible for the study, 70% of eligible children will be recruited; 80% of the tDCS sessions started will last the entire 20-minute duration, 75% of treatment sessions will be completed, and 90% of reassessments will occur in the 14 days following the final treatment session. Adherence to the study protocol will be tracked by the number of tDCS and physiotherapy sessions scheduled per week and the number actually completed. Reasons for cancelled sessions or decreased number of sessions booked will be documented. Because tDCS should optimally occur in the half hour prior to physiotherapy, the start time and duration of stimulation will be documented, as well as the start time and duration of each physiotherapy session, on tracking sheets that will be completed by the RA/therapist conducting each tDCS/physiotherapy session.
Gross Motor- Baseline assessments will be conducted by a blinded independent PT assessor in the two weeks prior to beginning the study treatment protocol. The reassessment will be conducted by the same blinded PT assessor up to two weeks after their last study intervention session. A priori targets for the co-primary gross motor outcomes are as follows: The active tDCS group should have at least 3 mean points of change more than the sham group on the Gross Motor Function Measure (GMFM) and at least 2.0 mean points of change more than the sham group on the Canadian Occupational Performance Measure (COPM).
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Hemiparesis
- Being tested
- active transcranial direct current stimulation, sham transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, physiotherapy, pediatric, motor learning
- Medical subject headings
- Brain Injuries, Stroke, Brain Injuries, Traumatic, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active transcranial direct current stimulationDevice
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 stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy + Active tDCS | Experimental | 20 minutes of active anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions. Receives: 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. Receives: Device: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Duration of study (approximately 2 years)
Enrollment Rate
The proportion of eligible participants who enrollment in the study.
Measured: Duration of study (approximately 2 years)
Adherence Rate
Proportion of participants who completed 10 treatment sessions
Measured: Duration of study (approximately 2 years)
Transcranial direct current stimulation tolerance
The proportion of tDCS sessions that were started lasting the entire treatment session
Measured: Duration of study (approximately 2 years)
Secondary outcomes (4)
Acquired Brain Injury Challenge Assessment (ABI-CA)
An 18-item standardized assessment of high level gross motor skills in children and youth with ABI. Each item assesses the child's ability to perform a skill and is scored on a 5-point scale according to time and quality of movement (where '5' indicates normal quality of movement and/or completion within a minimum amount of time while '0' indicates they were unable to complete the item within a maximum period of time and did not meet the criteria for quality).
Measured: Change from baseline to reassessment (4-6 weeks)
10m Fast Walk Test
Timed walk test over 10m with the participant walking as fast as possible.
Measured: Change from baseline to reassessment (4-6 weeks)
Goal Attainment Scaling
Participant-specific mobility, balance, and/or gross motor goals created by the treating physiotherapist to target specific activities they will work on in physiotherapy. The child's baseline ability is scored as a '-2'. The physiotherapist sets individualized targets for the child where '-1' indicates they are performing somewhat less than expected, '0' indicates they are performing at the expected level for a given time frame, '+1' indicates they have done somewhat better than expected, and '+2' indicates they have done much better than expected. When the goal is set, the physiotherapist sets '0' (the expected level) based on the timing of the reassessment and what they think the child is clinically capable of accomplishing in that time period.
Measured: Change from baseline to reassessment (4-6 weeks)
Pediatric Evaluation of Disability Inventory (Mobility and Self-Care domains)
Parent-reported computerized questionnaire evaluating their child's function ability. Each item is rated on 4-point scale where '0' indicates the child is unable to do and '4' indicates the activity is easy to do. A higher score indicates higher levels of independence with mobility and self-care.
Measured: Change from baseline to reassessment (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized feasibility trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deryk Beal, PhD, Principal investigator, Clinician ScientistVirginia Wright, PhD, Principal investigator, Clinician Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637957
- Sponsor's protocol ID
- 504
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Transcranial Direct Current Stimulation as an Adjunct to Outpatient Physiotherapy in Children With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05637957
- Acronym / sponsor ID
- 504
- Conditions
- Acquired Brain Injury, Stroke, Traumatic Brain Injury, Hemiparesis
- Keywords
- transcranial direct current stimulation, physiotherapy, pediatric, motor learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives: The purpose of this study is to evaluate the feasibility of tDCS as a pre-treatment adjunct to outpatient physiotherapy (our outpatient 'physio+tDCS' protocol) for children with stroke or TBI. The primary objective is to evaluate the feasibility of an outpatient twice weekly 'physio+tDCS' protocol given over five weeks, as measured by participant eligibility, recruitment, tolerance, retention, and adherence to treatment protocol (e.g., session frequency and completion timelines). The secondary objective is to explore the preliminary effect of physio+tDCS on gross motor function in children with childhood onset stroke and TBI, as measured by individualized goal achievement and standardized gross motor outcome measures.
Randomization and Blinding: Once enrolled in the study, an independent research assistant (RA) will randomly assign each child to the "sham" or "active" tDCS treatment group using a computer randomization web-based program. Only the RAs involved in the study will be aware of each participant's treatment group assignment. The participants and the assessing/treating PTs will be blinded to the participant's treatment group.
Intervention:
tDCS Treatment- Depending on treatment group allocation, participants will receive 20 minutes of active tDCS or sham tDCS (provided by a trained RA) immediately prior to two physiotherapy sessions each week for a total of 10 sessions. Children and PTs will be blinded to their tDCS/sham allocation. Two electrodes (5x7cm) in size will be used such that the anodal electrode will be attached to the C3/4 position on the scalp, to target the lower extremity region of the primary motor cortex most affected by their brain injury, and the cathodal electrode will be attached to the contralateral supraorbital (Fp1/Fp2) area of the forehead. Each tDCS treatment will consist of up to 2.0 mA of stimulation, adjusting for the child's age, head size, and tolerance as required. Participant symptoms and safety will be tracked before, during, and after each tDCS session. Adverse events reported via a REB-approved standard process to an independent in-house safety monitoring committee. Physiotherapy Intervention- The physiotherapy treatment paired with the tDCS consists of the typical motor skills-based physiotherapy children receive brain injury program at Holland Bloorview. Each 45-minute physiotherapy session promotes motor learning by focusing on functional tasks related to the child's personalized motor goals. Therapists individualize the program by adapting the tasks, instructions, feedback, and the level of challenge based on the child's needs.
Outcomes Feasibility- Feasibility of study implementation and tDCS will be evaluated by tracking process, resource, and treatment indicators. A priori feasibility targets are as follows: 30% of children indentified by the child's clinical physiotherapist or nurse will be eligible for the study, 70% of eligible children will be recruited; 80% of the tDCS sessions started will last the entire 20-minute duration, 75% of treatment sessions will be completed, and 90% of reassessments will occur in the 14 days following the final treatment session. Adherence to the study protocol will be tracked by the number of tDCS and physiotherapy sessions scheduled per week and the number actually completed. Reasons for cancelled sessions or decreased number of sessions booked will be documented. Because tDCS should optimally occur in the half hour prior to physiotherapy, the start time and duration of stimulation will be documented, as well as the start time and duration of each physiotherapy session, on tracking sheets that will be completed by the RA/therapist conducting each tDCS/physiotherapy session.
Gross Motor- Baseline assessments will be conducted by a blinded independent PT assessor in the two weeks prior to beginning the study treatment protocol. The reassessment will be conducted by the same blinded PT assessor up to two weeks after their last study intervention session. A priori targets for the co-primary gross motor outcomes are as follows: The active tDCS group should have at least 3 mean points of change more than the sham group on the Gross Motor Function Measure (GMFM) and at least 2.0 mean points of change more than the sham group on the Canadian Occupational Performance Measure (COPM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group randomized feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy + Active tDCS | Experimental | Device: active transcranial direct current stimulation20 minutes of active anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions. |
| Physiotherapy + Sham tDCS | Active comparator | Device: sham transcranial direct current stimulation20 minutes of sham anodal tDCS immediately prior to physiotherapy intervention, twice a week for total of 10 sessions. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active transcranial direct current stimulationDevice: 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 | Device | Physiotherapy + Active tDCS |
| sham transcranial direct current stimulationDevice: 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 | Device | Physiotherapy + Sham tDCS |
Primary outcome
Gross Motor Function Measure (GMFM-88)
Time frame: Change from baseline to reassessment (4-6 weeks)
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.
Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline to reassessment (4-6 weeks)
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.
Eligibility Rate
Time frame: Duration of study (approximately 2 years)
The proportion of eligible participants compared to the number of children identified by brain injury clinicians using preliminary screening checklist.
Enrollment Rate
Time frame: Duration of study (approximately 2 years)
The proportion of eligible participants who enrollment in the study.
Adherence Rate
Time frame: Duration of study (approximately 2 years)
Proportion of participants who completed 10 treatment sessions
Transcranial direct current stimulation tolerance
Time frame: Duration of study (approximately 2 years)
The proportion of tDCS sessions that were started lasting the entire treatment session
4 secondary outcomes
Acquired Brain Injury Challenge Assessment (ABI-CA)
Time frame: Change from baseline to reassessment (4-6 weeks)
10m Fast Walk Test
Time frame: Change from baseline to reassessment (4-6 weeks)
Goal Attainment Scaling
Time frame: Change from baseline to reassessment (4-6 weeks)
Pediatric Evaluation of Disability Inventory (Mobility and Self-Care domains)
Time frame: Change from baseline to reassessment (4-6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No. At this time data will not be shared with other researchers
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deryk Beal, PhD principal investigator
Clinician Scientist
Virginia Wright, PhD principal investigator
Clinician Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active transcranial direct current stimulation in people with Acquired Brain Injury and Stroke, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trina Mitchell, PhD (416-425-6220 ext. 3965, tmitchell@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM-88) (time frame: Change from baseline to reassessment (4-6 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.