N/A
Completed N=6
Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial
Spasmodic Dysphonia · Laryngeal Dystonia · Deep Brain Stimulation
Source: ClinicalTrials.gov NCT02558634 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Unified Spasmodic Dysphonia Rating Scale (USDRS) — 2.5; 3.75 units on a scale — p=0.025
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.
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 | — |
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.
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. Informational only — not medical advice.