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Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

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ClinicalTrials.gov Identifier: NCT02558634
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

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.


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: DBS-on

Ventral intermediate Nucleus (VIM) Thalamic DBS on

DBS system includes:

  • Implantable Pulse Generator (IPG)
  • DBS Lead
  • DBS Lead Extension Kit
Device: VIM Thalamic Deep Brain Stimulation ON
Sham Comparator: DBS-off (sham-stimulation)

Ventral intermediate Nucleus (VIM) Thalamic DBS off

DBS system includes:

  • Implantable Pulse Generator (IPG)
  • DBS Lead
  • DBS Lead Extension Kit
Device: VIM Thalamic Deep Brain Stimulation OFF



Primary Outcome Measures :
  1. 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.

  2. 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

  3. Adverse/Safety of DBS Implantation and Stimulation in SD [ Time Frame: 12 months ]
    Stimulation-induced side effects, intraoperative effects, problems with surgery


Secondary Outcome Measures :
  1. Beck's Depression Inventory Scale [ Time Frame: 12 months ]
  2. Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: 12 months ]
  3. Voice-Handicap Index [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Controlled Oral Word Association Test [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Canada, British Columbia
The Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E3
Contact: Christopher R Honey, MD, DPhil    604.875.5894    chris.honey@telus.net   
Sponsors and Collaborators
University of British Columbia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British Columbia
ClinicalTrials.gov Identifier: NCT02558634     History of Changes
Other Study ID Numbers: H15-02535
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Dystonia
Dysphonia
Hoarseness
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory