Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

University of British Columbia

Status: Completed

Conditions: Spasmodic Dysphonia; Laryngeal Dystonia; Deep Brain Stimulation

Treatments: Device: VIM Thalamic Deep Brain Stimulation OFF; Device: VIM Thalamic Deep Brain Stimulation ON

Study type: Interventional

Funder types: Other

Identifiers

NCT02558634

H15-02535

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

DBS-on

Experimental group

Description:

Ventral intermediate Nucleus (VIM) Thalamic DBS on DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit

Treatment:

Device: VIM Thalamic Deep Brain Stimulation ON

DBS-off (sham-stimulation)

Sham Comparator group

Description:

Ventral intermediate Nucleus (VIM) Thalamic DBS off DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit

Treatment:

Device: VIM Thalamic Deep Brain Stimulation OFF