Deep Brain Stimulation for Spasmodic Dysphonia and Tremor

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Hearing loss, Cortical venous anatomy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how Deep Brain Stimulation (DBS) affects voice control in patients with dystonia and essential tremor. DBS sends electrical impulses to brain areas that manage movement, aiming to improve voice function in these patients. Deep Brain Stimulation (DBS) has been used to treat severe movement disorders, including Parkinson's disease, dystonia, and essential tremor.

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Deep Brain Stimulation for Spasmodic Dysphonia and Tremor?

Research shows that Deep Brain Stimulation (DBS) can improve symptoms of spasmodic dysphonia (a voice disorder) and tremor. In a study, patients with both conditions experienced significant improvement, especially with stimulation on one side of the brain. This suggests DBS could be a promising treatment for these voice and movement disorders. ^{1 2 3 4 5}

Is Deep Brain Stimulation generally safe for humans?

Deep Brain Stimulation (DBS) has been used for various movement disorders like Parkinson's disease, but it can have complications such as infections, lead migrations, and device malfunctions. Some patients may experience neurobehavioral effects, and in certain cases, serious complications like cerebral bleeds or device-related trauma may occur, requiring further surgery. ^{6 7 8 9 10}

How is the treatment Deep Brain Stimulation (DBS) different from other treatments for spasmodic dysphonia?

Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to modulate neural circuits, offering a potentially long-lasting improvement for spasmodic dysphonia without the need for repeated injections like botulinum toxin A (BTX). Unlike BTX, which requires regular administration, DBS can provide continuous symptom relief and may address underlying neural pathways involved in the condition. ^{1 2 11 12 13}

Research Team

Kristina Simonyan, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

This trial is for adults aged 18-80 with voice disorders due to dystonia or essential tremor, who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to follow instructions, complete training, and give informed consent. They should not have obstructive venous anatomy, significant hearing loss, or inability to perform required tasks.

Inclusion Criteria

I can follow test instructions, complete training, and give informed consent.

I am between 18 and 80 years old.

I am approved for DBS surgery for my essential tremor or dystonia by a specialist team.

Exclusion Criteria

Your brain's veins could get in the way of placing electrodes during surgery.

I can understand and perform the tasks required in the study protocol.

I have significant hearing loss.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Data Collection

Electrophysiological data collection during DBS surgery for patients with dystonia or tremor

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in voice and motor function using clinical rating scales

5 years

Treatment Details

Interventions

• Deep Brain Stimulation (Procedure)

Trial Overview The study aims to understand how often voice disorders occur in patients with dystonia and essential tremor treated with DBS. It will explore the changes in brain imaging and activity related to voice dysfunction before and after the treatment.

Participant Groups

Group I: Electrophysiological signal data collection Experimental Treatment 1 Intervention

Patients diagnosed with dystonia or tremor who are recommended for DBS surgery. Electrophysiological data will be collected at the time of DBS surgery.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain
• Stroke-related motor deficits (under investigation)

🇪🇺 Approved in European Union as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

🇨🇦 Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California San Francisco San Francisco, CA

Massachusetts General Hospital Boston, MA

University of Utah Salt Lake City, UT

Massachusetts General Hospital, University of California San Francisco, University of Utah Boston, MA

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Patients Recruited

15,000+

UMASS Memorial Medical Center

Collaborator

Trials

4

Patients Recruited

3,900+

University of Iowa

Collaborator

Trials

486

Patients Recruited

934,000+

University of Utah

Collaborator

Trials

1169

Patients Recruited

1,623,000+

Massachusetts General Hospital

Collaborator

Trials

3066

Patients Recruited

13,430,000+

University of California, San Francisco

Collaborator

Trials

2636

Patients Recruited

19,080,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Spasmodic Dysphonia: A Blinded Comparison of Unilateral and Bilateral Stimulation in Two Patients. Krüger, MT., Hu, A., Honey, CR.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment of voice disorders. Hawkshaw, MJ., Sataloff, RT.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coprevalence of tremor with spasmodic dysphonia: a case-control study. White, LJ., Klein, AM., Hapner, ER., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice Improvement After Essential Tremor Treatment via Focused Ultrasound and Deep Brain Stimulation. Larner, P., Jonas, R., Gutierrez, CN., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voice-Related Outcomes in Deep Brain Stimulation in Patients with Vocal Tremor: A Systematic Review and Meta-Analysis. Lu, F., Zhao, K., Wu, Y., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. Alonso-Frech, F., Fernandez-Garcia, C., Gómez-Mayordomo, V., et al.[2022]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Unilateral Peri-Lead Edema Into Large Cystic Cavitation After Deep Brain Stimulation: A Case Report. Lu, Y., Qiu, C., Chang, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical reappraisal of DBS targeting for movement disorders. Guzzi, G., Della Torre, A., Chirchiglia, D., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of spasmodic dysphonia with a neuromodulating electrical implant. Pitman, MJ.[2014]

In a review of cases from 2012 to 2020, three patients with adductor spasmodic dysphonia (SD) and essential tremor showed significant improvement in their voice and limb tremors after undergoing bilateral thalamic deep brain stimulation (DBS).

The improvement in SD was specifically noted when higher stimulation amplitudes or wider pulse widths were used, indicating that the effectiveness of DBS for SD may depend on the settings used during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adductor Spasmodic Dysphonia Improves with Bilateral Thalamic Deep Brain Stimulation: Report of 3 Cases Done Asleep and Review of Literature. Evidente, VGH., Ponce, FA., Evidente, MH., et al.[2021]

Unilateral thalamic deep brain stimulation (DBS) significantly improved vocal function in a 79-year-old woman with spasmodic dysphonia (SD) and essential tremor, as shown by a decrease in Unified Spasmodic Dysphonia Rating Scale scores and improved voice-related quality of life.

The study found that stimulation of the ventral intermediate (Vim) nucleus was more effective than stimulation of the ventral oralis anterior (Voa) nucleus, suggesting that targeting specific neural circuits can enhance treatment outcomes for SD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of unilateral thalamic deep brain stimulation on the vocal dysfunction in a patient with spasmodic dysphonia: interrogating cerebellar and pallidal neural circuits. Poologaindran, A., Ivanishvili, Z., Morrison, MD., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Spasmodic Dysphonia: A Blinded Comparison of Unilateral and Bilateral Stimulation in Two Patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment of voice disorders. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Coprevalence of tremor with spasmodic dysphonia: a case-control study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Voice Improvement After Essential Tremor Treatment via Focused Ultrasound and Deep Brain Stimulation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Voice-Related Outcomes in Deep Brain Stimulation in Patients with Vocal Tremor: A Systematic Review and Meta-Analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Unilateral Peri-Lead Edema Into Large Cystic Cavitation After Deep Brain Stimulation: A Case Report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Critical reappraisal of DBS targeting for movement disorders. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of spasmodic dysphonia with a neuromodulating electrical implant. [2014]

12. England pubmed.ncbi.nlm.nih.gov

Adductor Spasmodic Dysphonia Improves with Bilateral Thalamic Deep Brain Stimulation: Report of 3 Cases Done Asleep and Review of Literature. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

The effect of unilateral thalamic deep brain stimulation on the vocal dysfunction in a patient with spasmodic dysphonia: interrogating cerebellar and pallidal neural circuits. [2019]