Deep Brain Stimulation for Pediatric Dystonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the development and progression of childhood dystonia, a movement disorder. Researchers seek to understand how brain activity changes in children with dystonia, particularly those with deep brain stimulation (DBS) devices. The trial uses noninvasive techniques to monitor brain and muscle activity, both at rest and during simple tasks, to assess how DBS affects motor functions. Eligible participants may include children with dystonia who have had DBS, those who have not, and typically developing children without neurological issues. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of childhood dystonia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that deep brain stimulation is safe for pediatric dystonia?
Research has shown that deep brain stimulation (DBS) in children with dystonia yields promising results. In one study involving 17 children, DBS improved movement abilities by an average of 36%, suggesting that the treatment can enhance motor skills.
Considering the safety of DBS is crucial. Reports on side effects in children with DBS indicate that while some complications may occur, the procedure is generally well-tolerated. These findings are based on both short- and long-term observations. Although some children might experience side effects, many have demonstrated positive long-term outcomes.
Overall, DBS appears to be a well-tolerated treatment option for children with dystonia, with a history of improving movement problems in many patients.12345Why are researchers excited about this trial?
Deep Brain Stimulation (DBS) is unique for pediatric dystonia because it offers a new way to manage symptoms by directly targeting brain activity. Unlike typical treatments like oral medications or botulinum toxin injections, which work to manage muscle contractions indirectly, DBS involves implanting electrodes in the brain to adjust abnormal signals that cause dystonia. Researchers are excited because this technique allows for adjustable and potentially reversible symptom control, providing a customizable approach that might offer relief when other treatments fall short.
What evidence suggests that Deep Brain Stimulation is effective for pediatric dystonia?
Research has shown that deep brain stimulation (DBS), the treatment under study in this trial, can significantly aid children with dystonia. Studies have found that it improves movement abilities, with some children experiencing up to a 93.2% improvement. Specifically, children with muscle jerking (myoclonus) and widespread dystonia showed improvements of 68.1% and 63.2%, respectively. DBS sends electrical signals to specific brain areas to help control unusual movements. It is particularly effective for certain genetic types of dystonia that begin in childhood. Overall, DBS offers promising results for managing symptoms and enhancing the quality of life for children with this condition.46789
Are You a Good Fit for This Trial?
This trial is for children with dystonia, a movement disorder. They should be able to complete study tasks and have normal development milestones without any neuropsychiatric disorders or significant medical conditions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo noninvasive electrophysiological measurements (EEG, EMG) to quantify neural network activity at rest and during a simple motor reaction task
DBS Assessment
Children with DBS are assessed in the on and off DBS state to evaluate effects of chronic and active changes in motor network function
Follow-up
Participants are monitored for safety and effectiveness after assessments
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation
Trial Overview
The study examines how neural networks in the brain change during motor development in kids with dystonia and measures the impact of Deep Brain Stimulation (DBS) on these networks through noninvasive tests like EEG and EMG.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with DBS will complete neurophysiological recordings with DBS on and off
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
Long-Term Outcomes of Deep Brain Stimulation for ...
Long-term outcomes showed a sustained motor benefit, with median Burke-Fahn-Marsden dystonia rating score improvement ranging from 2.5% to 93.2% ...
Long-Term Outcomes of Deep Brain Stimulation for ...
Long-term outcomes showed a sustained motor benefit, with median Burke-Fahn-Marsden dystonia rating score improvement ranging from 2.5% to 93.2% in different ...
3.
movementdisorders.onlinelibrary.wiley.com
movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30309Deep Brain Stimulation in Children and Adolescents with ε ...
Significant improvements were observed in myoclonus (68.1%), generalized dystonia (63.2%), and dystonia during writing (48.1%), walking (70.3%) ...
Three-stage DBS results in better outcomes for secondary ...
A CHOC neuroscientist has developed a breakthrough method of DBS to treat secondary dystonia in pediatric patients.
Deep Brain Stimulation for Pediatric Dystonia: A review of the ...
DBS is considered most effective in childhood-onset monogenic dystonia, including early-onset isolated dystonia (DYT-TOR1A), myoclonus-dystonia ...
Exploring the efficacy of deep brain stimulation in pediatric ...
A study summarized 17 pediatric PKAN cases, with an average follow-up period of 13 months after STN-DBS, the BFMDRS score improved by 36 ± 12.9 ...
Adverse events associated with deep brain stimulation in ...
We aim to expand the knowledge of pediatric DBS by providing data on short- and long-term AEs of patients with DBS implantation up to the age of 18 years ...
8.
movementdisorders.onlinelibrary.wiley.com
movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29516Long‐Term Follow‐Up of Pediatric Patients with Dyskinetic ...
Complications of deep brain stimulation (DBS) for dystonia in children-the challenges and 10 year experience in a large paediatric cohort.
Deep brain stimulation in children and young adults with ...
DBS has been shown to be most effective in patients with primary generalized dystonia, and patients with a DYT1 mutation are reported to have the best response.
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