Repetitive Transcranial Magnetic Stimulation for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a new treatment called repetitive transcranial magnetic stimulation (rTMS) to help children with cerebral palsy improve motor skills. The goal is to enhance brain adaptability, potentially speeding up rehabilitation and reducing long-term healthcare needs. Participants will be divided into groups to receive either active or sham (fake) rTMS. Children with cerebral palsy who can move around fairly well and have no history of major brain surgery or epilepsy may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation strategies for children with cerebral palsy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that repetitive transcranial magnetic stimulation is safe for children with cerebral palsy?
A previous study found repetitive transcranial magnetic stimulation (rTMS) safe for children, including those with cerebral palsy (CP). Most reported side effects were minor, such as headaches, and no major adverse events occurred. Research has shown that rTMS can improve motor function and is generally well-tolerated when applied to different brain areas. These findings suggest that rTMS is a safe treatment option, offering reassurance for those considering participation in clinical trials.12345
Why are researchers excited about this trial?
Researchers are excited about using repetitive transcranial magnetic stimulation (rTMS) for cerebral palsy because it offers a non-invasive way to potentially improve motor function. Unlike standard treatments that often rely on physical therapy or medication, rTMS uses magnetic fields to stimulate specific areas of the brain, which could enhance muscle control and coordination. This technique is distinct because it targets either the contralesional or ipsilesional primary motor cortex, allowing for tailored interventions. Plus, it promises quicker results as sessions are spread over just four weeks, making it a promising option for faster improvements in symptoms.
What evidence suggests that repetitive transcranial magnetic stimulation could be effective for cerebral palsy?
This trial will evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on children with cerebral palsy (CP). Participants in Intervention Group 1 will receive rTMS targeting the side of the brain opposite the injury. Studies have shown this can improve finger and hand movements. Intervention Group 2 will receive rTMS targeting the same side of the brain as the injury, which has been found to reduce muscle tightness and improve arm and hand function. Overall, rTMS supports better movement by altering brain activity to aid motor recovery.13678
Who Is on the Research Team?
Christos Papadelis, PhD
Principal Investigator
Cook Children's Health Care System
Are You a Good Fit for This Trial?
This trial is for children aged 6 to 18 with a confirmed diagnosis of cerebral palsy who are able to walk or move independently (high functioning, GMFCS levels I-III), can understand and follow instructions, and have normal vision and hearing (with or without correction).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive repetitive transcranial magnetic stimulation (rTMS) targeting motor cortex over 10 sessions, each lasting 20 minutes, spread over four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of TMS-evoked potentials and motor function
What Are the Treatments Tested in This Trial?
Interventions
- Repetitive Transcranial Magnetic Stimulation
Trial Overview
The study tests repetitive transcranial magnetic stimulation (rTMS) at different frequencies to see if it improves movement in kids with cerebral palsy. Brain activity will be measured using MRI and EEG before and after rTMS sessions.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
CP Participants in experiment intervention group 2 will receive rTMS targeting the ipsilesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks. Each session will start with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses. This will be followed immediately by 10 minutes of 10 Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 2000 high-frequency pulses.
CP participants in the experiment intervention group 1 will receive rTMS using a figure-of-eight-shaped coil and rTMS stimulator (Nexstim, Finland) targeting the contralesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks. Each session will begin with priming: 10 minutes of 6-Hz rTMS at 90% of the resting motor threshold, delivered in two trains per minute (5 seconds per train with 25-second intervals between trains), totaling 600 priming pulses. This will be followed immediately by 10 minutes of 1-Hz rTMS at 90% of the resting motor threshold, delivered continuously without interruption, totaling 600 low-frequency pulses.
Typically developed control group will complete a single baseline TMS-EEG session to measure TEPs. This involves high-density EEG recording during single-pulse TMS to assess cortical excitability. The session will last approximately 60-90 minutes.
CP participants in the sham group will receive sham rTMS by positioning the coil perpendicular to the scalp without delivering active stimulation, targeting both the contralesional and ipsilesional primary motor cortex. The intervention will consist of 10 sessions, each lasting 20 minutes, spread over four weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cook Children's Health Care System
Lead Sponsor
Citations
Effects of repetitive transcranial magnetic stimulation on motor ...
The rTMS could improve the motor function and language ability of patients with CP. However, rTMS prescriptions varied, and the studies had low sample sizes.
Repetitive transcranial magnetic stimulation influences ... - PMC
The rTMS applied to the left DLPFC is safe and effective in improving the performance of cognitive-motor dual-task in children with CP. Keywords ...
Primed low frequency repetitive transcranial magnetic ...
The active group received 6 Hz primed low-frequency 1Hz rTMS delivered to the contralesional primary motor cortex for 4 weeks, in 10 sessions. The placebo group ...
The Effectiveness of Repetitive Transcranial Magnetic ...
The objective of the project is to evaluate the effectiveness of a repetitive Transcranial Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to ...
Primed low frequency repetitive transcranial magnetic ...
The active group received 6 Hz primed low-frequency 1Hz rTMS delivered to the contralesional primary motor cortex for 4 weeks, in 10 sessions.
Unlocking the potential of repetitive transcranial magnetic ...
rTMS is safe for children with rare, minor side effects under safety guidelines. Abstract. Background. Cerebral Palsy (CP) poses a substantial challenge to ...
Increasing Number of Therapy Sessions of Repetitive ... - PMC
Repetitive transcranial magnetic stimulation of contralesional primary motor cortex improves hand function after stroke. Stroke. 2005;36:2681–6. doi ...
Safety and efficacy of non‐invasive brain stimulation for the ...
Evidence indicates that non-invasive brain stimulation (NIBS) is a safe and feasible intervention to target upper extremity outcomes in ...
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