Clinical trial NCT02558634: Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial
Official title: Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasmodic Dysphonia
Laryngeal Dystonia
Deep Brain Stimulation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Unified Spasmodic Dysphonia Rating Scale (USDRS)
timeFrame: After the first 6 months, the participants completed the USDRS twice (once per crossover).
measure: Voice-Related Quality of Life
timeFrame: After the first 6 months, the participants completed the V-RQoL twice (once per crossover).
Secondary outcomes:
measure: Beck's Depression Inventory Scale
timeFrame: All participants completed the BDI-II once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).
measure: Voice-Handicap Index
timeFrame: All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: UBC
name: Christopher R Honey, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ludlow CL, Adler CH, Berke GS, Bielamowicz SA, Blitzer A, Bressman SB, Hallett M, Jinnah HA, Juergens U, Martin SB, Perlmutter JS, Sapienza C, Singleton A, Tanner CM, Woodson GE. Research priorities in spasmodic dysphonia. Otolaryngol Head Neck Surg. 2008 Oct;139(4):495-505. doi: 10.1016/j.otohns.2008.05.624.
citation: Simonyan K, Tovar-Moll F, Ostuni J, Hallett M, Kalasinsky VF, Lewin-Smith MR, Rushing EJ, Vortmeyer AO, Ludlow CL. Focal white matter changes in spasmodic dysphonia: a combined diffusion tensor imaging and neuropathological study. Brain. 2008 Feb;131(Pt 2):447-59. doi: 10.1093/brain/awm303. Epub 2007 Dec 14.
citation: Honey CR, Kruger MT, Almeida T, Rammage LA, Tamber MS, Morrison MD, Poologaindran A, Hu A. Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Phase I Prospective Randomized Double-Blind Crossover Trial. Neurosurgery. 2021 Jun 15;89(1):45-52. doi: 10.1093/neuros/nyab095.
citation: Poologaindran A, Ivanishvili Z, Morrison MD, Rammage LA, Sandhu MK, Polyhronopoulos NE, Honey CR. The effect of unilateral thalamic deep brain stimulation on the vocal dysfunction in a patient with spasmodic dysphonia: interrogating cerebellar and pallidal neural circuits. J Neurosurg. 2018 Feb;128(2):575-582. doi: 10.3171/2016.10.JNS161025. Epub 2017 Mar 17.