Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial
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|ClinicalTrials.gov Identifier: NCT02558634|
Recruitment Status : Unknown
Verified January 2017 by Christopher Honey, University of British Columbia.
Recruitment status was: Recruiting
First Posted : September 24, 2015
Last Update Posted : January 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Spasmodic Dysphonia Laryngeal Dystonia Deep Brain Stimulation||Device: VIM Thalamic Deep Brain Stimulation ON Device: VIM Thalamic Deep Brain Stimulation OFF||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
Ventral intermediate Nucleus (VIM) Thalamic DBS on
DBS system includes:
Device: VIM Thalamic Deep Brain Stimulation ON
Sham Comparator: DBS-off (sham-stimulation)
Ventral intermediate Nucleus (VIM) Thalamic DBS off
DBS system includes:
Device: VIM Thalamic Deep Brain Stimulation OFF
- Unified Spasmodic Dysphonia Rating Scale (USDRS) [ Time Frame: 3 and 6 months ]Double-blinded assessments of spasmodic dysphonia with DBS ON/OFF will be conducted using a standardized spasmodic dysphonia rating scale.
- Voice-Related Quality of Life [ Time Frame: 3 and 6 months ]Double-blinded assessments of voice-related quality of life with DBS ON/OFF will be conducted using the Vr-QoL for Spasmodic Dysphonia
- Adverse/Safety of DBS Implantation and Stimulation in SD [ Time Frame: 12 months ]Stimulation-induced side effects, intraoperative effects, problems with surgery
- Beck's Depression Inventory Scale [ Time Frame: 12 months ]
- Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: 12 months ]
- Voice-Handicap Index [ Time Frame: 12 months ]
- Controlled Oral Word Association Test [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558634
|Canada, British Columbia|
|The Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E3|
|Contact: Christopher R Honey, MD, DPhil 604.875.5894 email@example.com|