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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is studying DBS to see if it can help people with spasmodic dysphonia.

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.Check my eligibility

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.See study design

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

Select...

I am currently receiving Botox treatments.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,413 Previous Clinical Trials

2,466,945 Total Patients Enrolled

1 Trials studying Spasmodic Dysphonia

6 Patients Enrolled for Spasmodic Dysphonia

Christopher R Honey, MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04938154 — Phase 2

Spasmodic Dysphonia Research Study Groups: DBS Off, DBS On

Spasmodic Dysphonia Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04938154 — Phase 2

Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938154 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project welcome people who are 80 years or older?

"According to the parameters set out by the researchers, individuals aged 18-75 can take part in this clinical trial. If you are outside of this age bracket, there are 3 other studies for those under 18 and 29 additional trials for patients over 65."

Answered by AI

Who meets the qualifications to participate in this research?

"Currently, this clinical trial is seeking to enroll 16 patients that suffer from hoarseness and are between 18-75 years old. The key requirements for participants are as follows: A diagnosis of spasmodic dysphonia from two different medical centres and currently receiving Botox treatments."

Answered by AI

What is the FDA's stance on DBS surgery?

"While Phase 2 trials have not yet provided efficacy data, the available safety data for DBS ON suggests that it is a safe procedure."

Answered by AI

Are there any patients that have not yet been enrolled in this research project?

"This trial, as detailed on clinicaltrials.gov, is not presently recruiting patients. The posting went up on 1/30/2023 and was last edited 10/31/2022. Despite this specific study being completed, there are 30 other open trials that participants can consider."

Answered by AI

Recent research and studies

Journal of VoiceJournal

Unilateral Versus Bilateral Injections of Botulinum Toxin in Patients with Adductor Spasmodic Dysphonia

Bielamowicz, Steven, Sheila V Stager, Andrea Badillo, and Alexis Godlewski. 2002. “Unilateral Versus Bilateral Injections of Botulinum Toxin in Patients with Adductor Spasmodic Dysphonia”. Journal of Voice. Elsevier BV. doi:10.1016/s0892-1997(02)00080-2.

The LaryngoscopeJournal

Coprevalence of Tremor with Spasmodic Dysphonia

White, Laura J., Adam M. Klein, Edie R. Hapner, John M. Delgaudio, John J. Hanfelt, Hyder A. Jinnah, and Michael M. Johns III. 2011. “Coprevalence of Tremor with Spasmodic Dysphonia”. The Laryngoscope. Wiley. doi:10.1002/lary.21872.

The LaryngoscopeJournal

Effects of Botulinum Toxin Therapy in Patients with Adductor Spasmodic Dysphonia: Acoustic, Aerodynamic, and Videoendoscopic Findings

Zwirner, Petra, Thomas Murry, Michael Swenson, and Gayle E. Woodson. 1992. “Effects of Botulinum Toxin Therapy in Patients with Adductor Spasmodic Dysphonia: Acoustic, Aerodynamic, and Videoendoscopic Findings”. The Laryngoscope. Wiley. doi:10.1288/00005537-199204000-00006.

Journal of Neurology, Neurosurgery & PsychiatryJournal