DBS for Spasmodic Dysphonia
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be receiving Botox treatments, it seems you may need to continue with those.
What data supports the effectiveness of the treatment Deep Brain Stimulation (DBS) for Spasmodic Dysphonia?
Preliminary results from a study showed that Deep Brain Stimulation (DBS) led to improvements in spasmodic dysphonia symptoms, especially with stimulation on one side of the brain. Additionally, patients with both spasmodic dysphonia and essential tremor experienced unexpected improvements in their voice symptoms after undergoing DBS for their tremor.12345
Is Deep Brain Stimulation (DBS) generally safe for humans?
Deep Brain Stimulation (DBS) has been used safely in humans for various conditions, including Parkinson's disease and essential tremor, although speech impairment can be a side effect. In studies for spasmodic dysphonia, DBS has shown improvements in symptoms with no major safety concerns reported.12367
How does the treatment Deep Brain Stimulation (DBS) differ from other treatments for spasmodic dysphonia?
Deep Brain Stimulation (DBS) is a unique treatment for spasmodic dysphonia because it targets the brain's neural circuits directly, unlike the standard treatment of botulinum toxin injections which temporarily weaken the throat muscles. DBS offers a more permanent solution by addressing the neurological cause of the condition, potentially reducing the need for frequent treatments.12378
What is the purpose of this trial?
This trial is testing Deep Brain Stimulation (DBS) for patients with Spasmodic Dysphonia who do not respond well to current treatments. DBS involves placing tiny electrodes in the brain to send electrical signals that help reduce muscle spasms and improve speech. Deep brain stimulation (DBS) is a promising new therapy for patients with spasmodic dysphonia (SD), showing good clinical effects in preliminary trials.
Research Team
Christopher R Honey, MD
Principal Investigator
University of British Columbia
Eligibility Criteria
This trial is for individuals with spasmodic dysphonia who are currently receiving Botox treatments. It's not suitable for those with muscle tension dysphonia, vocal tremor, mild symptoms, neurodegenerative diseases, laryngeal denervation surgery or intracranial pathology. Also excluded are patients with MRI contraindications like metal implants or certain medical devices.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Evaluation
Patients are evaluated by a laryngologist, a speech language pathologist, and a psychiatrist to confirm diagnosis and eligibility for surgery
Phase 2 Evaluation
Patients undergo further evaluation at the Indiana University Health Voice Centre, including high-speed videostroboscopy and acoustic recordings
Treatment
Randomized crossover trial with DBS On and DBS Off phases, followed by an open-label phase with active stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Deep Brain Stimulation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor