What side effects are associated with this type of intervention?

The most common treatment for Spasmodic Dysphonia is botulinum toxin (BTX) injections into the laryngeal muscles. Known side effects of BTX include temporary muscle weakness, pain at the injection site, and the potential development of antibodies against the toxin, which can reduce its effectiveness over time. Deep Brain Stimulation (DBS), a treatment being studied for SD, involves implanting electrodes in specific brain regions to block damaging signals. Side effects of DBS can include infection, bleeding, and hardware complications, as well as potential changes in mood or cognition.

What prior FDA approvals exist?

Currently, the FDA-approved treatment for Spasmodic Dysphonia (SD) involves the use of botulinum toxin (BTX) injections into the laryngeal muscles to temporarily reduce muscle spasms. This treatment requires repeated injections approximately every three months. While Deep Brain Stimulation (DBS) is being explored as a potential new treatment for SD, it has not yet received FDA approval for this specific condition. DBS involves the electrical stimulation of specific brain regions to block the damaging signals causing the disorder.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation (DBS) for Spasmodic Dysphonia (SD) patients include transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS). These non-invasive neuromodulation techniques have shown potential in treating various neurological and psychiatric conditions and could offer new avenues for SD treatment.

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Procedure

DBS for Spasmodic Dysphonia

Phase 2

Waitlist Available

Led By Christopher R Honey, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is receiving Botox treatments

Be older than 18 years old

Must not have

Patients who have muscle tension dysphonia or vocal tremor

Patients who have had laryngeal denervation surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of DBS may include headache, infection at the site of surgery, speech problems, balance issues, mood changes or depression. There might also be risks associated with the electrical stimulation itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving Botox treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a condition that causes abnormal bleeding.

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I have a condition that affects my brain or nerves.

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

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I have a brain condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Voice-Related Quality of Life as assessed by the Voice-Related Quality of Life questionnaire.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DBS OnExperimental Treatment1 Intervention

Group II: DBS OffPlacebo Group1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Spasmodic Dysphonia (SD) is botulinum toxin (BTX) injections, which work by temporarily weakening the laryngeal muscles to reduce spasms. This treatment, however, requires repeated injections and has a delayed onset of benefits. Deep Brain Stimulation (DBS), a neurosurgical procedure involving the implantation of electrodes to deliver electrical stimuli to specific brain regions, is being studied as an alternative. DBS aims to block the damaging signals causing the involuntary muscle contractions in SD, potentially offering a more consistent and long-term solution. This matters for SD patients as it could significantly improve their ability to communicate effectively and enhance their quality of life by providing more stable symptom control.