N/A N=6 Randomized Triple-blind Treatment

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

Spasmodic Dysphonia · Laryngeal Dystonia · Deep Brain Stimulation

Bottom Line

View on ClinicalTrials.gov: NCT02558634 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Unified Spasmodic Dysphonia Rating Scale (USDRS) — 2.5; 3.75 units on a scale — p=0.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VIM Thalamic Deep Brain Stimulation ON (Device); VIM Thalamic Deep Brain Stimulation OFF (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of British Columbia
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Unified Spasmodic Dysphonia Rating Scale (USDRS)	2.5; 3.75	0.025 sig
PRIMARY Voice-Related Quality of Life	74.7; 19	—
SECONDARY Beck's Depression Inventory Scale	13.33; 6.50	—
SECONDARY Montreal Cognitive Assessment Scale (MoCA)	24.17; 26.67	—
SECONDARY Voice-Handicap Index	84.83; 38.17	—

Summary

Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles. Current treatments such as botox and voice therapy only provide temporary relief and thus, the investigators are exploring new strategies to provide long-term, sustained improvement. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of electrodes to deliver electrical stimuli to specific brain regions. It is the standard surgical treatment for many other movement disorders such as Parkinson's disease, essential tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS can improve the vocal dysfunction of LD.

Eligibility Criteria

Inclusion Criteria

Clinically diagnosed isolated laryngeal dystonia (adductor spasmodic dysphonia)
Able to give informed consent
Patients who fall into the age range of 18-75 years old
Patients with inadequate medical and BTX management of spasmodic dysphonia

Exclusion Criteria

Dystonia present in other body parts (i.e- eyes, neck, limbs) in addition to larynx
History of laryngeal denervation surgery for spasmodic dysphonia
History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
Incompetent adults or those unable to communicate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02558634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.