DBS for Spasmodic Dysphonia

Overseen By Danielle Pietramala, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of British Columbia

Must be taking: Botox

Disqualifiers: Muscle tension dysphonia, Vocal tremor, Neurodegenerative disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Deep Brain Stimulation (DBS) as a new treatment for Spasmodic Dysphonia (SD), a condition causing involuntary muscle spasms that affect speech. DBS involves placing electrodes in the brain to block the signals causing these spasms. The trial aims to determine if DBS can provide more lasting relief compared to the current treatment of botulinum toxin (Botox) injections, which are temporary and often painful. Individuals diagnosed with SD and currently receiving Botox treatments might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance for potentially longer-lasting relief.

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 prior data suggests that Deep Brain Stimulation is safe for treating Spasmodic Dysphonia?

Research has shown that Deep Brain Stimulation (DBS) is safe for people with spasmodic dysphonia (SD). In a study on DBS for SD, researchers performed the procedure without major safety problems. The study indicated a strong trend toward improving the condition without causing harm.

DBS is already a well-known treatment for other movement disorders like Parkinson's disease, which supports its safety. The procedure involves placing small wires in the brain to send electrical signals, helping to block the harmful signals that cause symptoms.

While DBS is a promising option, any medical procedure can have risks. People interested in joining a trial should consult their doctor to understand what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spasmodic dysphonia?

Deep Brain Stimulation (DBS) is unique because it offers a novel approach to treating spasmodic dysphonia by directly targeting the brain. Unlike current treatments that typically involve botulinum toxin injections to relax the muscles, DBS works by using electrical impulses to regulate abnormal brain activity associated with voice disorders. Researchers are excited about DBS because it has the potential to provide more consistent and long-lasting symptom relief, reducing the need for frequent interventions. This technique could revolutionize the way we manage this condition by addressing its neurological roots rather than just the symptoms.

What evidence suggests that Deep Brain Stimulation might be an effective treatment for Spasmodic Dysphonia?

Research has shown that Deep Brain Stimulation (DBS) can alleviate symptoms of spasmodic dysphonia (SD). Studies have found that stimulating specific brain areas improves voice quality and reduces vocal spasms. For instance, patients experienced fewer speaking difficulties and voice tremors following DBS treatment. Their overall voice-related quality of life improved, indicating a positive impact on daily communication. In this trial, participants will be assigned to either a "DBS On" group, where the stimulation is active, or a "DBS Off" group, serving as a sham comparator. These findings suggest that DBS could be a promising long-term treatment for SD, offering more lasting benefits than current therapies like botulinum toxin injections. ^{2 4 5 6 7}

Who Is on the Research Team?

Christopher R Honey, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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

I have been diagnosed with spasmodic dysphonia by two different teams.

I am currently receiving Botox treatments.

Exclusion Criteria

I have muscle tension in my voice or a shaky voice.

I have had surgery to cut the nerves to my voice box.

I do not have any MRI contraindications such as metal implants, certain tattoos, or pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase 1 Evaluation

Patients are evaluated by a laryngologist, a speech language pathologist, and a psychiatrist to confirm diagnosis and eligibility for surgery

2-4 weeks

Multiple visits (in-person)

Phase 2 Evaluation

Patients undergo further evaluation at the Indiana University Health Voice Centre, including high-speed videostroboscopy and acoustic recordings

2-4 weeks

Multiple visits (in-person)

Treatment

Randomized crossover trial with DBS On and DBS Off phases, followed by an open-label phase with active stimulation

12 months

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The trial is testing Deep Brain Stimulation (DBS) as a treatment for spasmodic dysphonia. Participants will undergo a surgical procedure to implant electrodes in the brain and receive electrical stimuli to potentially alleviate involuntary muscle contractions affecting speech.

How Is the Trial Designed?

Group I: DBS On Experimental Treatment 1 Intervention

Group II: DBS Off Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

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]

In a study involving 5 subjects with spasmodic dysphonia, electrical stimulation of the thyroarytenoid muscle led to significant improvements in voice evaluations for 4 out of the 5 participants, suggesting the treatment's efficacy.

The study demonstrated the feasibility of implanting an electrical stimulation device in the thyroarytenoid muscle, indicating potential for a new treatment approach for spasmodic dysphonia through neuromodulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Deep brain stimulation (DBS) shows promising results for treating spasmodic dysphonia (SD), with unilateral left thalamic stimulation providing significant clinical effects in a small trial of 6 right-handed patients.

In two patients with both essential tremor and SD, bilateral thalamic DBS led to the most improvement, but unilateral stimulation was also effective, suggesting that the treatment's efficacy may depend on the patient's handedness and the dominant hemisphere for speech.

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11073779/

Deep Brain Stimulation Improves Symptoms of Spasmodic ... Stimulation of thalamic sensorimotor areas was associated with improvement in symptoms of spasmodic dysphonia.

2. frontierspartnerships.org frontierspartnerships.org/journals/dystonia/articles/10.3389/dyst.2025.15271/full

Is thalamic deep brain stimulation the right target to improve ... The DBS outcomes relevant to voice symptoms were assessed using Voice-Related Quality of Life (V-RQOL), Voice Handicap Index (VHI), and the Unified Spasmodic ...

3. medrxiv.org medrxiv.org/content/10.1101/2022.11.26.22282419v1

Deep brain stimulation improves symptoms of spasmodic ... Deep brain stimulation improves symptoms of spasmodic dysphonia through targeting of thalamic sensorimotor connectivity | medRxiv.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199723003028

Voice-Related Outcomes in Deep Brain Stimulation ... The results of this systematic review with meta-analysis suggest that DBS is significantly effective in controlling vocal tremors and enhancing the quality of ...

5. tremorjournal.org tremorjournal.org/articles/10.5334/tohm.575

Adductor Spasmodic Dysphonia Improves with Bilateral ... At one month post-DBS, her chokiness and dysarthria were markedly improved. She had much less difficulty speaking and no vocal tremor. At last ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33862624/

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia This phase I randomized controlled trial confirmed that DBS can be performed safely in patients with SD. Blinded DBS produced a strong trend ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715922006134

Deep Brain Stimulation for Spasmodic Dysphonia: A Phase ... This phase I randomized controlled trial confirmed that DBS can be performed safely in patients with SD. Blinded DBS produced a strong trend toward improved ...