Clinical Trial: Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial

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.


Detailed Summary:
Sponsor: University of British Columbia

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • Unified Spasmodic Dysphonia Rating Scale (USDRS) [ Time Frame: 12 months ]
    This standardized laryngeal dystonia rating scale will be used to assess the efficacy of DBS.
  • Voice-Related Quality of Life [ Time Frame: 12 Months ]
    Standard quality of life scales will also be conducted


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Beck's Depression Inventory Scale [ Time Frame: 12 months ]
  • Cerebral Metabolic Changes measured by Fludeoxyglucose (FDG)-PET [ Time Frame: 12 months ]


Information By: University of British Columbia

Dates:
Date Received: September 22, 2015
Date Started: January 2016
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017