DBS for Spasmodic Dysphonia

Palo Alto (17 mi)

Overseen byChristopher R Honey, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

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.

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

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 have a condition that causes abnormal bleeding.

I have a condition that affects my brain or nerves.

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

I have a brain condition.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DBS OnExperimental Treatment1 Intervention

Group II: DBS OffPlacebo Group1 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: