Cerebral PalsyNCT04902521
Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Pediatric Unilateral Cerebral Palsy
A study testing Transcranial magnetic stimulation in people with Cerebral Palsy, run by University of Manitoba at 1 site in Canada.
Trial summary
Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial to improving outcomes in these patients. Constraint-induced movement therapy (CIMT) has become a standard therapeutic intervention for children with unilateral CP. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Transcranial magnetic 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 Dec 2023
- 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 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of unilateral spastic CP
- assessed as Gross Motor Function Classification System level I to III
- assessed as Manual Ability Classification System level II to level IV
Who cannot join
- have received CIMT in the last 6 month
- do not have neuroimaging studies to confirm clinical diagnosis of CP
- severe impairments limiting their ability to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
SSCY/RCC
Winnipeg, Manitoba, R3E3G1
Florencia Ricci, MD, PhD, fricci@hsc.ca
About this study
Official title: Concurrent Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Feasibility Study
Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial to improving outcomes in these patients. Constraint-induced movement therapy (CIMT) has become a standard therapeutic intervention for children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.
Transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to improve symptoms of children with neurodevelopmental disorders such as CP. It is predicted that a combined therapy that uses CIMT and TMS is could improve mobility in children with unilateral CP.
Read more
To determine if combined therapy is beneficial to children with CP and if use of this therapy is feasible for families, the investigators would like to conducted a feasibility trial. In this trial the investigators will enrol 10 children who have unilateral CP, the participants will either receive:
- CIMT and TMS or;
- CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.
The aim of this project is to determine if it is feasible to conduct a large randomized control trial to compare the effects of combined CIMT and TMS versus CIMT and fake TMS.The investigators also hope that by conducting this trial they can identify any benefits that the addition of TMS may have in children with CP.
Read the detailed description
Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial in optimizing neuroplasticity and improving outcomes. One such intervention is constraint-induced movement therapy (CIMT), a therapeutic approach used in children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.CIMT is more effective than other rehabilitation approaches in improving upper limb function and has become a standard therapeutic intervention for children with unilateral CP.
Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP.
A recent Canadian study, the PLASTIC Champs trial, demonstrated that combining TMS and CIMT for children with unilateral CP secondary to perinatal stroke produced greater improvements in upper limb function when compared to CIMT or TMS alone. Though promising, there are three features of the Plastic Champs trial that could limit its generalizability. First, it took place in a very special, intensive setting of daily CIMT/TMS during a 14-day camp. Second is the single cause of CP studied. And finally, it included only school-age children. To date, no research study has evaluated if findings from the PLASTIC Champs trial could be replicated when utilizing the combination of CIMT and TMS in a regular clinical environment, and among younger children.
A feasibility study is an appropriate first step towards our plan of performing a definitive RCT on the topic.
In this trial the investigators will enrol 10 children who have unilateral CP, they will either receive:
- CIMT and TMS or;
- CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.
The Investigators seek to evaluate whether, in younger children, the addition of TMS to the more commonly used, intermittent outpatient regimen of CIMT improves the motor outcomes of the upper limb.
- Conditions
- Cerebral Palsy
- Being tested
- Transcranial magnetic stimulation, Sham Transcranial Magnetic stimulation
- Keywords
- cerebral palsy, constrain induced muscle therapy, Transcranial magnetic stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Also called TMS
Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP
Sham Transcranial Magnetic stimulationDevice
Also called Sham TMS
Sham Transcranial Magnetic stimulation will be given to the control group. During the Sham procedure patients will sit near the TMS but will not receive any magnetic pulses.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation with constraint induced movement therapy | Experimental | CIMT/TMS: Five participants will receive a one-hour weekly occupational therapy session of CIMT with 2-hours of daily home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of TMS 1HZ. Receives: Device: Transcranial magnetic stimulation |
| constraint induced movement therapy Sham transcrianial magnetic stimulation | Sham comparator | (CIMT/sham TMS): Five participants will receive a one-hour weekly session of CIMT with 2-hours daily of home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of sham TMS 1HZ. Receives: Device: Sham Transcranial Magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Participant recruitment
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
Measured: 5 Months
Evaluation of Participant retention during trial
We will assess and report the number of missing variables and number of patients with incomplete outcome measures.
Measured: 5 Months
Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports
We will ask parents to report weekly on the presence of previously reported side effects including headaches, anxiety, dizziness, tingling, mood changes, difficulties with concentration, abnormal muscle contractions, nausea, stomach ache, fatigue and decreased hand function of either hand. For completeness we will also ask about presence of seizures (new onset or increase in existing seizures), although this side effect was not seen in previous safety studies. We will also assess number of times (and reasons) TMS session ended before the stipulated time and number of minutes lost.
Measured: 5 Months
Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist
TMS sham process and blinding of patients and therapist: At the end of the study we will ask parents/ occupational therapist assessing outcomes to report on possible group allocation of participant (could they identify if the participant received TMS or sham TMS?)
Measured: 5 months
Evaluation of treatment intervention by parental guardians
Acceptability of treatment: Based on Gillick's work, at the end of the intervention (6 weeks) and 3 months post completion, we will ask parents to rate on a scale of 1 to 10 their "satisfaction with the intervention, willingness to repeat the study, and likelihood of recommending the study to others." .
- Participant research engagement: At the end of the study we will ask parents to rate their willingness to participate as a research-collaborator in a future large RCT study.
Measured: 3 months
Estimation of intervention costs
This study will provide information needed to develop a budget for the future application.
Measured: 5 months
Secondary outcomes (2)
Assessment of mobility using Small Kids-AHA
We will assess differences between pre-to post intervention using the Small Kids- AHA scores among those undergoing CIMT+TMS vs. CIMT/sham TMS. Small Kids-AHA is a measure of bimanual performance and is rated on a scale or 0-100 (100 being high functionality).
Measured: 5 months
Assessment of mobility using the Canadian Occupational Performance Measure (COPM)
We will assess differences between pre-to post intervention using the Canadian Occupational Performance Measure (COPM) scores among those undergoing CIMT+TMS vs. CIMT/sham TMS. Canadian Occupational Performance Measure is used to asses daily functioning and is scored on a 10 point scale (10 being high functionality).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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 Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Florencia Ricci, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902521
- Sponsor's protocol ID
- HS24766(B2021:023)
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
PubMed 28715518Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
PubMed 21950396Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to treat motor disorders. Prog Brain Res. 2013;207:379-401. doi: 10.1016/B978-0-444-63327-9.00015-1.
PubMed 24309263Chen YP, Pope S, Tyler D, Warren GL. Effectiveness of constraint-induced movement therapy on upper-extremity function in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2014 Oct;28(10):939-53. doi: 10.1177/0269215514544982. Epub 2014 Aug 14.
PubMed 25125440Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
PubMed 24366991Eliasson AC, Holmefur M. The influence of early modified constraint-induced movement therapy training on the longitudinal development of hand function in children with unilateral cerebral palsy. Dev Med Child Neurol. 2015 Jan;57(1):89-94. doi: 10.1111/dmcn.12589. Epub 2014 Sep 19.
PubMed 25236758Masuda F, Nakajima S, Miyazaki T, Tarumi R, Ogyu K, Wada M, Tsugawa S, Croarkin PE, Mimura M, Noda Y. Clinical effectiveness of repetitive transcranial magnetic stimulation treatment in children and adolescents with neurodevelopmental disorders: A systematic review. Autism. 2019 Oct;23(7):1614-1629. doi: 10.1177/1362361318822502. Epub 2019 Jan 20.
PubMed 30663323Kirton 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04902521
- Acronym / sponsor ID
- HS24766(B2021:023)
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, constrain induced muscle therapy, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 May 2021 (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.
Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial to improving outcomes in these patients. Constraint-induced movement therapy (CIMT) has become a standard therapeutic intervention for children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.
Transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to improve symptoms of children with neurodevelopmental disorders such as CP. It is predicted that a combined therapy that uses CIMT and TMS is could improve mobility in children with unilateral CP.
To determine if combined therapy is beneficial to children with CP and if use of this therapy is feasible for families, the investigators would like to conducted a feasibility trial. In this trial the investigators will enrol 10 children who have unilateral CP, the participants will either receive:
- CIMT and TMS or;
- CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.
The aim of this project is to determine if it is feasible to conduct a large randomized control trial to compare the effects of combined CIMT and TMS versus CIMT and fake TMS.The investigators also hope that by conducting this trial they can identify any benefits that the addition of TMS may have in children with CP.
Detailed description
Cerebral Palsy (CP) is the most common cause of childhood physical disability. Early CP diagnosis and intervention are crucial in optimizing neuroplasticity and improving outcomes. One such intervention is constraint-induced movement therapy (CIMT), a therapeutic approach used in children with unilateral CP. CIMT utilizes restraining of the unaffected upper limb to stimulate the use of the paretic upper limb enhancing neuroplasticity in the affected cerebral hemisphere.CIMT is more effective than other rehabilitation approaches in improving upper limb function and has become a standard therapeutic intervention for children with unilateral CP.
Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP.
A recent Canadian study, the PLASTIC Champs trial, demonstrated that combining TMS and CIMT for children with unilateral CP secondary to perinatal stroke produced greater improvements in upper limb function when compared to CIMT or TMS alone. Though promising, there are three features of the Plastic Champs trial that could limit its generalizability. First, it took place in a very special, intensive setting of daily CIMT/TMS during a 14-day camp. Second is the single cause of CP studied. And finally, it included only school-age children. To date, no research study has evaluated if findings from the PLASTIC Champs trial could be replicated when utilizing the combination of CIMT and TMS in a regular clinical environment, and among younger children.
A feasibility study is an appropriate first step towards our plan of performing a definitive RCT on the topic.
In this trial the investigators will enrol 10 children who have unilateral CP, they will either receive:
- CIMT and TMS or;
- CIMT and fake TMS, fake TMS consist of a child sitting near the TMS machine but not receiving any TMS.
The Investigators seek to evaluate whether, in younger children, the addition of TMS to the more commonly used, intermittent outpatient regimen of CIMT improves the motor outcomes of the upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation with constraint induced movement therapy | Experimental | Device: Transcranial magnetic stimulationCIMT/TMS: Five participants will receive a one-hour weekly occupational therapy session of CIMT with 2-hours of daily home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of TMS 1HZ. |
| constraint induced movement therapy Sham transcrianial magnetic stimulation | Sham comparator | Device: Sham Transcranial Magnetic stimulation(CIMT/sham TMS): Five participants will receive a one-hour weekly session of CIMT with 2-hours daily of home program for a total of 6 weeks; immediately prior to initiation of each CIMT session, participants will receive 20 minutes of sham TMS 1HZ. |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosis of unilateral spastic CP
- assessed as Gross Motor Function Classification System level I to III
- assessed as Manual Ability Classification System level II to level IV
Key exclusion criteria (3 listed)
- have received CIMT in the last 6 month
- do not have neuroimaging studies to confirm clinical diagnosis of CP
- severe impairments limiting their ability to participate
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 |
|---|---|---|
| Transcranial magnetic stimulationAlso: TMSRepetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP | Device | Transcranial magnetic stimulation with constraint induced movement therapy |
| Sham Transcranial Magnetic stimulationAlso: Sham TMSSham Transcranial Magnetic stimulation will be given to the control group. During the Sham procedure patients will sit near the TMS but will not receive any magnetic pulses. | Device | constraint induced movement therapy Sham transcrianial magnetic stimulation |
Primary outcome
Evaluation of Participant recruitment
Time frame: 5 Months
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
Evaluation of Participant retention during trial
Time frame: 5 Months
We will assess and report the number of missing variables and number of patients with incomplete outcome measures.
Incidence of Treatment-Emergent Adverse Events as assessed by Parental Reports
Time frame: 5 Months
We will ask parents to report weekly on the presence of previously reported side effects including headaches, anxiety, dizziness, tingling, mood changes, difficulties with concentration, abnormal muscle contractions, nausea, stomach ache, fatigue and decreased hand function of either hand. For completeness we will also ask about presence of seizures (new onset or increase in existing seizures), although this side effect was not seen in previous safety studies. We will also assess number of times (and reasons) TMS session ended before the stipulated time and number of minutes lost.
Effectiveness of the transcrainial magnetic stimulation blinding process on patients and therapist
Time frame: 5 months
TMS sham process and blinding of patients and therapist: At the end of the study we will ask parents/ occupational therapist assessing outcomes to report on possible group allocation of participant (could they identify if the participant received TMS or sham TMS?)
Evaluation of treatment intervention by parental guardians
Time frame: 3 months
Acceptability of treatment: Based on Gillick's work, at the end of the intervention (6 weeks) and 3 months post completion, we will ask parents to rate on a scale of 1 to 10 their "satisfaction with the intervention, willingness to repeat the study, and likelihood of recommending the study to others." . - Participant research engagement: At the end of the study we will ask parents to rate their willingness to participate as a research-collaborator in a future large RCT study.
Estimation of intervention costs
Time frame: 5 months
This study will provide information needed to develop a budget for the future application.
2 secondary outcomes
Assessment of mobility using Small Kids-AHA
Time frame: 5 months
Assessment of mobility using the Canadian Occupational Performance Measure (COPM)
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 28715518Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
- Background: PubMed 21950396Gordon AM. To constrain or not to constrain, and other stories of intensive upper extremity training for children with unilateral cerebral palsy. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:56-61. doi: 10.1111/j.1469-8749.2011.04066.x.
- Background: PubMed 24309263Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to treat motor disorders. Prog Brain Res. 2013;207:379-401. doi: 10.1016/B978-0-444-63327-9.00015-1.
- Background: PubMed 25125440Chen YP, Pope S, Tyler D, Warren GL. Effectiveness of constraint-induced movement therapy on upper-extremity function in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2014 Oct;28(10):939-53. doi: 10.1177/0269215514544982. Epub 2014 Aug 14.
- Background: PubMed 24366991Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
- Background: PubMed 25236758Eliasson AC, Holmefur M. The influence of early modified constraint-induced movement therapy training on the longitudinal development of hand function in children with unilateral cerebral palsy. Dev Med Child Neurol. 2015 Jan;57(1):89-94. doi: 10.1111/dmcn.12589. Epub 2014 Sep 19.
- Background: PubMed 30663323Masuda F, Nakajima S, Miyazaki T, Tarumi R, Ogyu K, Wada M, Tsugawa S, Croarkin PE, Mimura M, Noda Y. Clinical effectiveness of repetitive transcranial magnetic stimulation treatment in children and adolescents with neurodevelopmental disorders: A systematic review. Autism. 2019 Oct;23(7):1614-1629. doi: 10.1177/1362361318822502. Epub 2019 Jan 20.
- Background: 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Cerebral Palsy, run by University of Manitoba 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 3 inclusion and 3 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 9 Jun 2023. 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. Some participants in this study may receive a placebo. 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 Florencia Ricci, MD, PhD (2042586549, fricci@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Participant recruitment (time frame: 5 Months). 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?
On the ClinicalTrials.gov record for NCT04902521, 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 9 Jun 2023.