StrokePhase 2/3PLASTIC CHAMPSNCT01189058
Modulation of Brain Plasticity After Perinatal Stroke
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Constraint-induced movement therapy (CIMT) in people with Stroke and Cerebral Palsy, run by University of Calgary at 1 site in Canada.
Trial summary
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects thousands of Canadian children and families. Treatments for CP are generally ineffective, and have traditionally focused on the weak body rather than the injured brain. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Stroke, Cerebral Palsy
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Constraint-induced movement therapy (CIMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Mar 2014
- Phase
- Phase 2/3
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic hemiplegic CP with impairment(s) of the upper extremity including the hand (Pediatric Stroke Outcome Measure motor >0.5; AND Manual Ability Classification System I, II,III, or IV; AND both child and parent perceive functional limitations (able to identify personally meaningful deficits in function).
- MRI confirmed AIS-MCA or PVI (neuroradiological syndrome classified by two blinded, experienced investigators according to previously validated methods)
- Age at enrollment: 6-18 years
- Resident in province of Alberta for period of study
- Informed consent/assent
Who cannot join
- Multifocal perinatal stroke or other brain injury/abnormality
- Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
- Intellectual disability causing an inability to comply with study protocol
- Unstable epilepsy (>1 seizure/month or >2 medication changes (dose or agent) in the last 6 months or history of recurrent status epilepticus)
- Any TMS contraindication including implanted electronic devices
- Botulinum toxin A injection in the affected upper extremity within the preceding 6 months
- Orthopedic surgery in the affected upper extremity in the previous 12 months
- Unwilling to delay any new therapeutic rehabilitational intervention directed towards upper limb function (aside from study home program) for the 6 month duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects thousands of Canadian children and families. Treatments for CP are generally ineffective, and have traditionally focused on the weak body rather than the injured brain. Understanding how the newborn brain responds to injuries like stroke (plasticity) carries the greatest potential for better treatments. We propose to study the ability of two interventions to modulate brain plasticity toward better function in children with stroke-induced CP. One is a rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe and comfortable for children and we recently showed it could improve motor function in children with stroke.
We will perform a special study to test both treatments simultaneously. Children 7-18 years with stroke-induced CP will be recruited into the study from across Alberta. Each child will randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending our new HemiKids Power Camp for motor learning. Improvements will be measured by trained therapists over 1 year. TMS will also measure brain plasticity, both initially and following treatment. Our lead investigator is an expert in both newborn stroke and TMS and has assembled an experienced team of accomplished collaborators to ensure the completion of this important work. This will be the largest study of children with CP examined in this manner. This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the largest trial of CIMT (and the first exclusive to newborn stroke), and the first study allowing the direct comparison of two different therapies. In establishing the first dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity changes in newborn stroke, advancing new treatments of this previously untreatable and disabling disease.
Patient recruitment is currently underway at Alberta Children's Hospital. Application is currently underway to expand recruitment to Northern Alberta through the Glenrose Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern Alberta greater opportunity to participate as subjects in this study.
Read the detailed description
Perinatal stroke is the leading cause of the most common term-born cerebral palsy: hemiplegic CP (HCP). With morbidity spanning all aspects of a child's life and lasting for decades, global impact is large. Mechanisms are poorly understood and prevention strategies remain elusive. Treatments are limited, leading to loss of hope in children and families that merits exploration of new interventions. Constraint-induced movement therapy (CIMT) may benefit but proper clinical trials are required. The investigators clinical-radiographic classifications have established perinatal stroke syndromes correlating with neurological outcome. Most common are: (1) arterial ischemic stroke of the middle cerebral artery (AIS-MCA) featuring cortical and subcortical damage acquired at birth and (2) periventricular venous infarction (PVI), a novel subcortical injury acquired in utero. These syndromes differ in the essential variables for plastic organization after perinatal injury: location and timing. In addition, recent animal and human studies suggest they may share a similar maladaptive plasticity whereby motor control of the weak side is "installed" in the non-lesioned hemisphere during development. Despite the ideal plasticity model such focal injury in a young brain provides, studies have been limited and suffer from small numbers of older patients with heterogeneous lesions. The value of studying plastic organization will be realized upon translation into meaningful patient benefits.
Transcranial magnetic stimulation (TMS) offers non-invasive measurement of the neurophysiological brain properties underlying neuroplasticity. Repetitive TMS (rTMS) may modulate such systems with therapeutic effect. the investigators recently demonstrated the ability of rTMS to improve motor function in children with chronic stroke. Advances in perinatal brain injury and neurodevelopment are, for the first time, affording novel windows of opportunity for interventions to direct plastic organization toward better outcomes. Via the Alberta Perinatal Stroke Project (APSP), the investigators propose a clinical trial of two interventions to improve function in HCP while measuring the fundamental neurophysiological properties at play.
Aim 1. Determine if rTMS and CIMT can improve motor function in HCP. Hypothesis: Two weeks of daily rTMS improves motor function at 30 days.
Aim 2. Define the neurophysiology of motor organization in stroke-induced HCP at baseline and following rTMS and CIMT.
Hypothesis: rTMS and CIMT reduce excitability of the non-lesioned motor cortex.
Population-based studies through the Alberta Perinatal Stroke Project (APSP) are establishing the largest perinatal stroke cohort to date. The investigators will complete a factorial 2 x 2 randomized clinical trial to determine the ability of daily rTMS and CIMT to improve motor function in children with HCP. Families will attend a child-centered, custom-designed intensive motor learning rehabilitation program (KidsCan Power Camp) for 2 weeks. Outcomes include validated measures of motor function and CP quality of life. The investigators will simultaneously measure the neurophysiology of plastic organization using TMS including cortical excitability, interhemispheric inhibition, and short interval intracortical inhibition. Baseline measures will define organization patterns while post-interventional measurement will evaluate the neurophysiological effects of rTMS and CIMT. Four groups of 16 children each (n=64) will be studied over 24 months with interim safety analysis after 10 and 32 patients.
Successful completion is assured by principle investigator experience in perinatal stroke and TMS and the collaborative support of world leaders in pediatric and adult stroke, TMS, basic neuroscience, and physiatry/rehabilitation. Understanding perinatal stroke plasticity and discovering methods to modulate it toward better outcomes carries a large impact, greatest for children with CP and their families.
- Conditions
- Stroke, Cerebral Palsy
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Constraint-induced movement therapy (CIMT)
- Keywords
- Perinatal stroke, Periventricular venous infarction, Presumed perinatal stroke, Neonatal stroke, Arterial ischemic stroke, Fetal stroke, Transcranial magnetic stimulation, Constraint-induced movement therapy, CIMT, Cerebral palsy, Congenital hemiplegia, Hemiplegic cerebral palsy, Neuroplasticity, Developmental plasticity
- Medical subject headings
- Stroke, Cerebral Palsy, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
TMS can affect discrete functional ares of motor cortex offering non-invasive, painless mapping and modulation of motor systems. Inhibitory rTMS (1Hz)has been shown to safely lower motor cortex excitability in normal patients as well as adult and pediatric stroke patients. Dose is 20 minutes per day (1200 stimulations) x 10 days administered over the non-lesioned M1.
Constraint-induced movement therapy (CIMT)Procedure or surgery
CIMT uses gentle restraint of the fully functional upper extremity to promote functional gains in the affected upper extremity. CIMT is well established to be safe and is likely effective in children with hemiplegic cerebral palsy, many of whom have perinatal stroke as studied here. A custom-fitted, bivalved cast is applied and worn for >90% of waking hours for the 2 weeks of active treatment according to protocol with daily assessments for comfort.
| Study group | Role | What they receive |
|---|---|---|
| rTMS and CIMT | Experimental | This group will receive both rTMS and CIMT. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS); Procedure: Constraint-induced movement therapy (CIMT) |
| rTMS and no CIMT | Experimental | This group will receive rTMS only. Receives: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham and CIMT | Experimental | This group will receive CIMT and sham rTMS. Receives: Procedure: Constraint-induced movement therapy (CIMT) |
| Sham and no CIMT | No intervention | This group will receive sham rTMS and no CIMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM).
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Measured: Completed 2 weeks or less before treatment day 1
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Measured: Completed day 5 after treatment day 10
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Measured: Completed 2 months after treatment day 10
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Measured: Completed 6 months after treatment day 10
Secondary outcomes (47)
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication.
Measured: Completed 2 weeks or less before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication.
Measured: Completed 5 days after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication.
Measured: Completed 2 months after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health. The PedsQL-CP is a condition specific health related quality of life instrument validated for child self-report (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participants. The PedsQL-CP includes scales of: daily activities, school activities, movement/balance, pain/hurt, fatigue, eating activities, and speech/communication.
Measured: Completed 6 months after treatment day 10
Pediatric Stroke Outcome Measure Short Neuro Exam Child Version (>2 years)(PSOM)
This is a validated outcome measure for perinatal and childhood stroke.
Measured: Completed before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents.
Measured: Completed 2 weeks or less before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents.
Measured: Completed day 5 after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents.
Measured: Completed 2 months after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
This instrument assesses domains of social/emotional well-being/acceptance, functioning, participation and physical health, access to services, pain and feelings about disability, and family health from a parents perspective. The PedsQL-CP is a condition specific health related quality of life instrument validated for parent-report of their child (5-18yrs). Version of PedsQL-CP used is age specific and will be completed by all participant's parents.
Measured: Completed 6 months after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release.
Measured: Completed 2 weeks or less prior to treatment day 1
SHUEE (Shriners Hospital Upper Extremity Evaluation)
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release.
Measured: Completed day 5 after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release.
Measured: Completed 2 months after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and dynamic positional analysis and assesses the ability to perform grasp and release.
Measured: Completed 6 months after treatment day 10
Box and Blocks Test
Tests the total number of blocks moved in 60 Seconds by each participant.
Measured: Completed 2 weeks or less before treatment day 1
Box and Blocks Test
Tests the total number of blocks moved in 60 Seconds by each participant.
Measured: Completed 5 days after treatment day 10
Box and Blocks Test
Tests the total number of blocks moved in 60 Seconds by each participant.
Measured: Completed 2 months after treatment day 10
Box and Blocks Test
Tests the total number of blocks moved in 60 Seconds by each participant.
Measured: Completed 6 months after treatment day 10
TMS Tolerability Measure
This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale.
Measured: Completed 2 weeks or less before treatment day 1
TMS Tolerability Measure
This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale.
Measured: Completed 5days after treatment day 10
TMS Tolerability Measure
This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale.
Measured: Completed 2 months after treatment day 10
TMS Tolerability Measure
This child reportable tool evaluates potential side effects or unpleasant features a child may experience after receiving TMS or Sham. Children are also asked to rate their TMS or Sham experience using a 1(most pleasant or enjoyable)- 8(most unpleasant or unenjoyable) scale.
Measured: Completed 6 months after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy.
Measured: Completed 2 weeks or less before treatment day 1
Grip and Pinch Strength Measures (GS, PS)
Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy.
Measured: Completed 5 days after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy.
Measured: Completed 2 months after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Grip and pinch strength (GS, PS) are simple, quick measures of motor power, quantifiable with hand dynamometer that have been evaluated in children with Hemiplegic Cerebral Palsy.
Measured: Comopleted 6 months after treatment day 10
Assisting Hand Assessment (AHA)
Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials.
Measured: Completed 2 weeks or less before treatment day 1
Assisting Hand Assessment (AHA)
Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials.
Measured: Completed 5 days after treatment day 10
Assisting Hand Assessment (AHA)
Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials.
Measured: Completed 2 months after treatment day 10
Assisting Hand Assessment (AHA)
Assisting Hand Assessment (AHA) is a sensitive, reliable, and validated assessment of bi-manual tasks (functional assistive role of the weak hand) in children with HCP. The AHA has excellent clini-metric properties for evaluating bi-manual hand activities in HCP and pCIMT trials.
Measured: Completed 6 months after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis.
Measured: Completed 2 weeks or less before treatment day 1
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis.
Measured: Completed 5 days after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis.
Measured: Completed 2 months after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
A validated, criterion-referenced functional measure designed to detect therapeutic clinical change in children with HCP. Testing in children with moderate CP demonstrates high intra and inter-rater reliabilities and construct validity. We have demonstrated the utility of the MAUULF in the only previous rTMS trial in children 7-20 years with stroke-induced hemiparesis.
Measured: Completed 6 months after treatment day 10
ABILHAND-Kids -Manual ability measure
Measures manual ability in children (ages 6-15) with CP as perceived by the parents.
Measured: Completed 2 weeks or less before treatment day 1
ABILHAND-Kids -Manual ability measure
Measures manual ability in children (ages 6-15) with CP as perceived by the parents.
Measured: Completed 5 days after treatment day 10
ABILHAND-Kids -Manual ability measure
Measures manual ability in children (ages 6-15) with CP as perceived by the parents.
Measured: Completed 2 months after treatment day 10
ABILHAND-Kids -Manual ability measure
Measures manual ability in children (ages 6-15) with CP as perceived by the parents.
Measured: Completed 6 months after treatment day 10
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children.
Measured: Completed 2 weeks or less before treatment day 1
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children.
Measured: Completed 5days after treatment day 10
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children.
Measured: Completed 2 months after treatment day 10
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Motor activity questionaire which asks parents to rate how often and how well their child uses his or her affected arm to complete some everyday activities. TMAL is used for Teenagers and PMAL is used for younger children.
Measured: Completed 6 months after treatment day 10
Biometrics Data Sheet
Records results of 3 groups of computer calibrated games 1. Eclipse which assesses pinch strength, 2. Space Shooter which assesses hand pronation and supination and 3. Balls and buckets which assesses wrist flexion and extension. Speed level, difficulty level, Range and percentage scores are recorded.
Measured: Completed each day during the 10 day camp program
Paediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE)-Child Version (Children Aged 2yrs and Older)
This neurological assessment tool assesses a child's: Level of Consciousness, Behaviour, Mental Status, Language, Cranial Nerves, Motor Movements, Tendon Reflexes, Fine Motor Coordination, Sensory and Gait, and rates any deficits using 0 (none), 0.5 (mild), 1.0 (Moderate) to 2 (severe) scale.
Measured: Completed before treatment day 1
Home Program Log
Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis.
Measured: Completed by each participant everyday during treatments days 1-10
Home Program Log
Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis.
Measured: Reassessed 2 months after treatment day 10
Home Program Log
Participants are asked to complete a home log which records which activities, Part A (Functional goal areas with 2 hands for 10 minutes)and Part B (Strengthening activities with affected hand for 5 minutes) they have completed at home on a daily basis.
Measured: Reassessed 6 months after treatment day 10
Camp Evaluation Form
This evaluation tool asked participants to rate their experience in attending the PLASTIC CHAMPS camp.
Measured: Completed by participants on Day 10 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, University of Alberta
- Responsible party
- Principal investigator, Adam Kirton, University of Calgary
- Investigators
- Adam Kirton, MD MSc FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189058
- Sponsor's protocol ID
- 22163
- Acronym
- PLASTIC CHAMPS
- Status last verified
- Oct 2013
- First submitted
- 20 Aug 2010
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirton A, Shroff M, Pontigon AM, deVeber G. Risk factors and presentations of periventricular venous infarction vs arterial presumed perinatal ischemic stroke. Arch Neurol. 2010 Jul;67(7):842-8. doi: 10.1001/archneurol.2010.140.
PubMed 20625091Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and interhemispheric inhibition after subcortical pediatric stroke: plastic organization and effects of rTMS. Clin Neurophysiol. 2010 Nov;121(11):1922-9. doi: 10.1016/j.clinph.2010.04.021.
PubMed 20537584Kirton A, Wei X. Teaching neuroimages: confirmation of prenatal periventricular venous infarction with susceptibility-weighted MRI. Neurology. 2010 Mar 23;74(12):e48. doi: 10.1212/WNL.0b013e3181d5a47a. No abstract available.
PubMed 20308675Kirton A, deVeber G. Advances in perinatal ischemic stroke. Pediatr Neurol. 2009 Mar;40(3):205-14. doi: 10.1016/j.pediatrneurol.2008.09.018.
PubMed 19218034Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet Neurol. 2008 Jun;7(6):507-13. doi: 10.1016/S1474-4422(08)70096-6. Epub 2008 May 1.
PubMed 18455961Kirton A, Deveber G, Pontigon AM, Macgregor D, Shroff M. Presumed perinatal ischemic stroke: vascular classification predicts outcomes. Ann Neurol. 2008 Apr;63(4):436-43. doi: 10.1002/ana.21334.
PubMed 18306227Kirton A, Westmacott R, deVeber G. Pediatric stroke: rehabilitation of focal injury in the developing brain. NeuroRehabilitation. 2007;22(5):371-82.
PubMed 18162700Raju TN, Nelson KB, Ferriero D, Lynch JK; NICHD-NINDS Perinatal Stroke Workshop Participants. Ischemic perinatal stroke: summary of a workshop sponsored by the National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke. Pediatrics. 2007 Sep;120(3):609-16. doi: 10.1542/peds.2007-0336.
PubMed 17766535Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
PubMed 27029628
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
- ClinicalTrials.gov ID
- NCT01189058
- Acronym / sponsor ID
- PLASTIC CHAMPS / 22163
- Conditions
- Stroke, Cerebral Palsy
- Keywords
- Perinatal stroke, Periventricular venous infarction, Presumed perinatal stroke, Neonatal stroke, Arterial ischemic stroke, Fetal stroke, Transcranial magnetic stimulation, Constraint-induced movement therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, University of Alberta
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 26 Aug 2010 (estimated)
- 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.
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects thousands of Canadian children and families. Treatments for CP are generally ineffective, and have traditionally focused on the weak body rather than the injured brain. Understanding how the newborn brain responds to injuries like stroke (plasticity) carries the greatest potential for better treatments. We propose to study the ability of two interventions to modulate brain plasticity toward better function in children with stroke-induced CP. One is a rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe and comfortable for children and we recently showed it could improve motor function in children with stroke.
We will perform a special study to test both treatments simultaneously. Children 7-18 years with stroke-induced CP will be recruited into the study from across Alberta. Each child will randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending our new HemiKids Power Camp for motor learning. Improvements will be measured by trained therapists over 1 year. TMS will also measure brain plasticity, both initially and following treatment. Our lead investigator is an expert in both newborn stroke and TMS and has assembled an experienced team of accomplished collaborators to ensure the completion of this important work. This will be the largest study of children with CP examined in this manner. This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the largest trial of CIMT (and the first exclusive to newborn stroke), and the first study allowing the direct comparison of two different therapies. In establishing the first dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity changes in newborn stroke, advancing new treatments of this previously untreatable and disabling disease.
Patient recruitment is currently underway at Alberta Children's Hospital. Application is currently underway to expand recruitment to Northern Alberta through the Glenrose Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern Alberta greater opportunity to participate as subjects in this study.
Detailed description
Perinatal stroke is the leading cause of the most common term-born cerebral palsy: hemiplegic CP (HCP). With morbidity spanning all aspects of a child's life and lasting for decades, global impact is large. Mechanisms are poorly understood and prevention strategies remain elusive. Treatments are limited, leading to loss of hope in children and families that merits exploration of new interventions. Constraint-induced movement therapy (CIMT) may benefit but proper clinical trials are required. The investigators clinical-radiographic classifications have established perinatal stroke syndromes correlating with neurological outcome. Most common are: (1) arterial ischemic stroke of the middle cerebral artery (AIS-MCA) featuring cortical and subcortical damage acquired at birth and (2) periventricular venous infarction (PVI), a novel subcortical injury acquired in utero. These syndromes differ in the essential variables for plastic organization after perinatal injury: location and timing. In addition, recent animal and human studies suggest they may share a similar maladaptive plasticity whereby motor control of the weak side is "installed" in the non-lesioned hemisphere during development. Despite the ideal plasticity model such focal injury in a young brain provides, studies have been limited and suffer from small numbers of older patients with heterogeneous lesions. The value of studying plastic organization will be realized upon translation into meaningful patient benefits.
Transcranial magnetic stimulation (TMS) offers non-invasive measurement of the neurophysiological brain properties underlying neuroplasticity. Repetitive TMS (rTMS) may modulate such systems with therapeutic effect. the investigators recently demonstrated the ability of rTMS to improve motor function in children with chronic stroke. Advances in perinatal brain injury and neurodevelopment are, for the first time, affording novel windows of opportunity for interventions to direct plastic organization toward better outcomes. Via the Alberta Perinatal Stroke Project (APSP), the investigators propose a clinical trial of two interventions to improve function in HCP while measuring the fundamental neurophysiological properties at play.
Aim 1. Determine if rTMS and CIMT can improve motor function in HCP. Hypothesis: Two weeks of daily rTMS improves motor function at 30 days.
Aim 2. Define the neurophysiology of motor organization in stroke-induced HCP at baseline and following rTMS and CIMT.
Hypothesis: rTMS and CIMT reduce excitability of the non-lesioned motor cortex.
Population-based studies through the Alberta Perinatal Stroke Project (APSP) are establishing the largest perinatal stroke cohort to date. The investigators will complete a factorial 2 x 2 randomized clinical trial to determine the ability of daily rTMS and CIMT to improve motor function in children with HCP. Families will attend a child-centered, custom-designed intensive motor learning rehabilitation program (KidsCan Power Camp) for 2 weeks. Outcomes include validated measures of motor function and CP quality of life. The investigators will simultaneously measure the neurophysiology of plastic organization using TMS including cortical excitability, interhemispheric inhibition, and short interval intracortical inhibition. Baseline measures will define organization patterns while post-interventional measurement will evaluate the neurophysiological effects of rTMS and CIMT. Four groups of 16 children each (n=64) will be studied over 24 months with interim safety analysis after 10 and 32 patients.
Successful completion is assured by principle investigator experience in perinatal stroke and TMS and the collaborative support of world leaders in pediatric and adult stroke, TMS, basic neuroscience, and physiatry/rehabilitation. Understanding perinatal stroke plasticity and discovering methods to modulate it toward better outcomes carries a large impact, greatest for children with CP and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rTMS and CIMT | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS), Procedure: Constraint-induced movement therapy (CIMT)This group will receive both rTMS and CIMT. |
| rTMS and no CIMT | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)This group will receive rTMS only. |
| Sham and CIMT | Experimental | Procedure: Constraint-induced movement therapy (CIMT)This group will receive CIMT and sham rTMS. |
| Sham and no CIMT | No intervention | –This group will receive sham rTMS and no CIMT. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Symptomatic hemiplegic CP with impairment(s) of the upper extremity including the hand (Pediatric Stroke Outcome Measure motor >0.5; AND Manual Ability Classification System I, II,III, or IV; AND both child and parent perceive functional limitations (able to identify personally meaningful deficits in function).
- MRI confirmed AIS-MCA or PVI (neuroradiological syndrome classified by two blinded, experienced investigators according to previously validated methods)
- Age at enrollment: 6-18 years
- Resident in province of Alberta for period of study
- Informed consent/assent
Key exclusion criteria (8 listed)
- Multifocal perinatal stroke or other brain injury/abnormality
- Severe hemiparesis (no voluntary contraction in paretic hand, MACS level V)
- Intellectual disability causing an inability to comply with study protocol
- Unstable epilepsy (>1 seizure/month or >2 medication changes (dose or agent) in the last 6 months or history of recurrent status epilepticus)
- Any TMS contraindication including implanted electronic devices
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)TMS can affect discrete functional ares of motor cortex offering non-invasive, painless mapping and modulation of motor systems. Inhibitory rTMS (1Hz)has been shown to safely lower motor cortex excitability in normal patients as well as adult and pediatric stroke patients. Dose is 20 minutes per day (1200 stimulations) x 10 days administered over the non-lesioned M1. | Procedure or surgery | rTMS and CIMT, rTMS and no CIMT |
| Constraint-induced movement therapy (CIMT)CIMT uses gentle restraint of the fully functional upper extremity to promote functional gains in the affected upper extremity. CIMT is well established to be safe and is likely effective in children with hemiplegic cerebral palsy, many of whom have perinatal stroke as studied here. A custom-fitted, bivalved cast is applied and worn for >90% of waking hours for the 2 weeks of active treatment according to protocol with daily assessments for comfort. | Procedure or surgery | Sham and CIMT, rTMS and CIMT |
Primary outcome
Canadian Occupational Performance Measure (COPM).
Time frame: Completed 2 weeks or less before treatment day 1
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Canadian Occupational Performance Measure (COPM)
Time frame: Completed day 5 after treatment day 10
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Canadian Occupational Performance Measure (COPM)
Time frame: Completed 2 months after treatment day 10
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Canadian Occupational Performance Measure (COPM)
Time frame: Completed 6 months after treatment day 10
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
47 secondary outcomes
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
Time frame: Completed 2 weeks or less before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
Time frame: Completed 5 days after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
Time frame: Completed 2 months after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)
Time frame: Completed 6 months after treatment day 10
Pediatric Stroke Outcome Measure Short Neuro Exam Child Version (>2 years)(PSOM)
Time frame: Completed before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
Time frame: Completed 2 weeks or less before treatment day 1
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
Time frame: Completed day 5 after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
Time frame: Completed 2 months after treatment day 10
PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)
Time frame: Completed 6 months after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
Time frame: Completed 2 weeks or less prior to treatment day 1
SHUEE (Shriners Hospital Upper Extremity Evaluation)
Time frame: Completed day 5 after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
Time frame: Completed 2 months after treatment day 10
SHUEE (Shriners Hospital Upper Extremity Evaluation)
Time frame: Completed 6 months after treatment day 10
Box and Blocks Test
Time frame: Completed 2 weeks or less before treatment day 1
Box and Blocks Test
Time frame: Completed 5 days after treatment day 10
Box and Blocks Test
Time frame: Completed 2 months after treatment day 10
Box and Blocks Test
Time frame: Completed 6 months after treatment day 10
TMS Tolerability Measure
Time frame: Completed 2 weeks or less before treatment day 1
TMS Tolerability Measure
Time frame: Completed 5days after treatment day 10
TMS Tolerability Measure
Time frame: Completed 2 months after treatment day 10
TMS Tolerability Measure
Time frame: Completed 6 months after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Time frame: Completed 2 weeks or less before treatment day 1
Grip and Pinch Strength Measures (GS, PS)
Time frame: Completed 5 days after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Time frame: Completed 2 months after treatment day 10
Grip and Pinch Strength Measures (GS, PS)
Time frame: Comopleted 6 months after treatment day 10
Assisting Hand Assessment (AHA)
Time frame: Completed 2 weeks or less before treatment day 1
Assisting Hand Assessment (AHA)
Time frame: Completed 5 days after treatment day 10
Assisting Hand Assessment (AHA)
Time frame: Completed 2 months after treatment day 10
Assisting Hand Assessment (AHA)
Time frame: Completed 6 months after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
Time frame: Completed 2 weeks or less before treatment day 1
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
Time frame: Completed 5 days after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
Time frame: Completed 2 months after treatment day 10
Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)
Time frame: Completed 6 months after treatment day 10
ABILHAND-Kids -Manual ability measure
Time frame: Completed 2 weeks or less before treatment day 1
ABILHAND-Kids -Manual ability measure
Time frame: Completed 5 days after treatment day 10
ABILHAND-Kids -Manual ability measure
Time frame: Completed 2 months after treatment day 10
ABILHAND-Kids -Manual ability measure
Time frame: Completed 6 months after treatment day 10
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Time frame: Completed 2 weeks or less before treatment day 1
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Time frame: Completed 5days after treatment day 10
The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)
Time frame: Completed 2 months after treatment day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Background: PubMed 20625091Kirton A, Shroff M, Pontigon AM, deVeber G. Risk factors and presentations of periventricular venous infarction vs arterial presumed perinatal ischemic stroke. Arch Neurol. 2010 Jul;67(7):842-8. doi: 10.1001/archneurol.2010.140.
- Background: PubMed 20537584Kirton A, Deveber G, Gunraj C, Chen R. Cortical excitability and interhemispheric inhibition after subcortical pediatric stroke: plastic organization and effects of rTMS. Clin Neurophysiol. 2010 Nov;121(11):1922-9. doi: 10.1016/j.clinph.2010.04.021.
- Background: PubMed 20308675Kirton A, Wei X. Teaching neuroimages: confirmation of prenatal periventricular venous infarction with susceptibility-weighted MRI. Neurology. 2010 Mar 23;74(12):e48. doi: 10.1212/WNL.0b013e3181d5a47a. No abstract available.
- Background: PubMed 19218034Kirton A, deVeber G. Advances in perinatal ischemic stroke. Pediatr Neurol. 2009 Mar;40(3):205-14. doi: 10.1016/j.pediatrneurol.2008.09.018.
- Background: PubMed 18455961Kirton A, Chen R, Friefeld S, Gunraj C, Pontigon AM, Deveber G. Contralesional repetitive transcranial magnetic stimulation for chronic hemiparesis in subcortical paediatric stroke: a randomised trial. Lancet Neurol. 2008 Jun;7(6):507-13. doi: 10.1016/S1474-4422(08)70096-6. Epub 2008 May 1.
- Background: PubMed 18306227Kirton A, Deveber G, Pontigon AM, Macgregor D, Shroff M. Presumed perinatal ischemic stroke: vascular classification predicts outcomes. Ann Neurol. 2008 Apr;63(4):436-43. doi: 10.1002/ana.21334.
- Background: PubMed 18162700Kirton A, Westmacott R, deVeber G. Pediatric stroke: rehabilitation of focal injury in the developing brain. NeuroRehabilitation. 2007;22(5):371-82.
- Background: PubMed 17766535Raju TN, Nelson KB, Ferriero D, Lynch JK; NICHD-NINDS Perinatal Stroke Workshop Participants. Ischemic perinatal stroke: summary of a workshop sponsored by the National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke. Pediatrics. 2007 Sep;120(3):609-16. doi: 10.1542/peds.2007-0336.
- Derived from this study: PubMed 27029628Kirton A, Andersen J, Herrero M, Nettel-Aguirre A, Carsolio L, Damji O, Keess J, Mineyko A, Hodge J, Hill MD. Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial. Neurology. 2016 May 3;86(18):1659-67. doi: 10.1212/WNL.0000000000002646. Epub 2016 Mar 30.
- Program WebsiteLink provided by the sponsor.
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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.
Adam Kirton, MD MSc FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Constraint-induced movement therapy (CIMT) in people with Stroke and Cerebral Palsy, run by University of Calgary 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 5 inclusion and 8 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 23 Oct 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM). (time frame: Completed 2 weeks or less before treatment day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189058, which also lists 9 linked publications.
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 23 Oct 2013.