Concurrent Use of Transcranial Magnetic Stimulation and Constraint Induced Movement Therapy in Children With Unilateral Cerebral Palsy: A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- University of Manitoba
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Evaluation of Participant retention during trial
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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. 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: 1. CIMT and TMS or; 2. 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.
Investigators
M. Florencia Ricci
Principle Investigator, Developmental Pediatrician
University of Manitoba
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
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.
Evaluation of Participant recruitment
Time Frame: 5 Months
Participant recruitment: We will assess number of eligible children, reasons for ineligibility and non-participation.
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?)
Estimation of intervention costs
Time Frame: 5 months
This study will provide information needed to develop a budget for the future application.
Secondary Outcomes
- Assessment of mobility using Small Kids-AHA(5 months)
- Assessment of mobility using the Canadian Occupational Performance Measure (COPM)(5 months)