Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spasmodic Dysphonia Laryngeal Dystonia Deep Brain Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DBS-on

Ventral intermediate Nucleus (VIM) Thalamic DBS on

DBS system includes:

* Implantable Pulse Generator (IPG)
* DBS Lead
* DBS Lead Extension Kit

Group Type EXPERIMENTAL

VIM Thalamic Deep Brain Stimulation ON

Intervention Type DEVICE

DBS-off (sham-stimulation)

Ventral intermediate Nucleus (VIM) Thalamic DBS off

DBS system includes:

* Implantable Pulse Generator (IPG)
* DBS Lead
* DBS Lead Extension Kit

Group Type SHAM_COMPARATOR

VIM Thalamic Deep Brain Stimulation OFF

Intervention Type DEVICE

Interventions

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VIM Thalamic Deep Brain Stimulation ON

Intervention Type DEVICE

VIM Thalamic Deep Brain Stimulation OFF

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No