Deep Brain Stimulation for Spasmodic Dysphonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how Deep Brain Stimulation (DBS), a surgical treatment using electrical signals to control abnormal brain activity, can assist individuals with Adductor Laryngeal Dystonia (ADLD). ADLD affects the vocal cords and makes speaking difficult. Participants will undergo DBS surgery, and researchers will study changes in vocal cord movements and brain activity to optimize this treatment. The trial seeks individuals with ADLD, possibly with additional tremors, who have not received botulinum toxin treatment for at least three months and are fully symptomatic. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to developing a potentially effective therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, any medication that might interfere with the safety of the surgery or research protocols could be a concern, so it's best to discuss your specific medications with the study team.
What prior data suggests that Deep Brain Stimulation is safe for treating laryngeal dystonia?
Research has shown that Deep Brain Stimulation (DBS) is generally safe for individuals with conditions like dystonia, which affects muscle control. In studies on similar conditions, patients have demonstrated improvements in symptoms and overall well-being. For instance, research on other types of dystonia, such as neck dystonia, suggests that DBS can enhance symptoms and mood.
Regarding safety, DBS has been tested in various forms of dystonia and is usually well-tolerated. Reports indicate that serious side effects are rare. In some studies, patients experienced improvements in voice symptoms without significant negative effects.
Overall, while no treatment is without risk, existing evidence suggests that DBS for dystonia is safe for most patients. It is important to discuss any concerns with a medical professional.12345Why are researchers excited about this trial?
Most treatments for laryngeal dystonia, like botulinum toxin injections, focus on temporarily relaxing the affected muscles to alleviate symptoms. However, Deep Brain Stimulation (DBS) is unique because it targets the brain directly, potentially addressing the root cause of the muscle spasms by modulating abnormal brain activity. Researchers are excited about DBS because it offers a more precise, long-term solution that could improve voice outcomes significantly without the frequent interventions that current treatments require. By using DBS, there's hope for a more stable and sustained improvement in symptoms for patients with laryngeal dystonia.
What evidence suggests that Deep Brain Stimulation might be an effective treatment for laryngeal dystonia?
Research has shown that Deep Brain Stimulation (DBS), the treatment under study in this trial, can help treat dystonia, a movement disorder that causes muscles to tighten uncontrollably. Studies have found that DBS effectively reduces symptoms when targeting specific brain areas, such as the globus pallidus pars interna and the subthalamic nucleus. For laryngeal dystonia, which affects the vocal cords, early research suggests DBS might improve voice symptoms. One study reported varying levels of improvement in voice symptoms with this treatment. However, more research is needed to confirm these benefits specifically for laryngeal dystonia.12346
Who Is on the Research Team?
Rita Patel, PhD
Principal Investigator
Indiana University
S. Elizabeth Zauber, MD
Principal Investigator
Indiana University
Kunal Gupta, MD, PhD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Assessment
Participants undergo specialized testing including vocal cord movement studies and functional magnetic resonance imaging (fMRI) before surgery
Surgery
Deep Brain Stimulation surgery is performed, and microelectrode recording is conducted during the procedure
Post-Surgery Assessment
After surgery, participants undergo activation of the deep brain stimulator, repeat speech testing, vocal cord imaging, and MRI
Follow-up
Participants are monitored for changes in voice outcomes, neuropsychological testing, and functional MRI 6-9 months after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Deep Brain Stimulation
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Voice outcomes and Magnetic resonance imaging will be compared pre- and post-DBS (Deep brain stimulation) in patients with laryngeal dystonia and adductor laryngeal dystonia. The evaluators will be masked for analyzing the voice outcomes pre-and post-DBS
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?
Indiana University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Citations
Deep Brain Stimulation for Laryngeal Dystonia: From ...
This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD).
2.
frontierspartnerships.org
frontierspartnerships.org/journals/dystonia/articles/10.3389/dyst.2025.15271/fullIs thalamic deep brain stimulation the right target to improve ...
Unlike tremor, DBS of the globus pallidus pars interna (GPi-DBS) and the subthalamic nucleus (STN-DBS) are most effective in reducing dystonic symptoms, ...
Thalamic Deep Brain Stimulation for Spasmodic Dysphonia
The results indicate that deep brain stimulation is safe in this patient population and suggest effectiveness. The lack of statistically ...
4.
simonyanlab.meei.harvard.edu
simonyanlab.meei.harvard.edu/project-3-deep-brain-stimulation-in-laryngeal-dystonia-and-voice-tremor-2/Project 3: Deep Brain Stimulation in Laryngeal Dystonia ...
For example, deep brain stimulation (DBS) effectively reduces limb dystonia and tremor in these patients, but the modulation of voice symptoms by DBS has been ...
Neuromodulation for Laryngeal Dystonia: A Systematic ...
All included studies reported various degrees of improvement in patients' voice symptoms with the neuromodulation therapy used. ... No significant ...
Deep brain stimulation for dystonia - Rodrigues, FB - 2019
The results showed that for neck dystonia, DBS may improve symptoms, clinical status, functioning, and mood.
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