Stimulation of the Thalamus to Ameliorate Parkinsonian Speech Disfluencies: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 3
- Primary Endpoint
- Change of One-Page Suttering Assessment from Baseline to Post-Operation
Study Overview
Brief Summary
The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). The team proposes to perform unilateral DBS on 3 patients with PD stutter refractory to intensive speech therapy, to determine a response in their PD stutter. The assessments will be double-blinded. The investigators will use the outcome of this case series to determine the feasibility and details of a larger randomized controlled trial.
Detailed Description
Purpose: The purpose is to assess if dominant thalamic Deep Brain Stimulation (DBS) is an effective treatment for Parkinsonian stutter. Functional magnetic resonance imaging (MRI) will detect brain dominance before surgery. The research team will assess whether dominant thalamic DBS is preferable for stutter treatment.
Hypothesis: The research team hypothesizes that dominant thalamic neuromodulation with DBS effectively treats PD stutter.
Justification:
The investigators initially began investigating the possibility of treatment of Stutter with DBS when they had a patient whose stutter serendipitously improved following thalamic DBS for tremor. The patient had severe tremor requiring bilateral thalamic DBS; he coincidentally had stutter. Post-operatively, the patient noted that he had had marked improvement in his tremor as well as his stutter. This prompted a literature search, where the investigators found that this has previously been reported in one other patient. Previous investigations of spasmodic dysphonia show that speech (similar to language) is lateralized in most patients, and that unilateral treatment of the dominant hemisphere is as beneficial as bilateral treatment.
Objectives: The objective is to perform a case series of three patients to assess feasibility and determine design of a future, larger study. If there is an appreciable reduction in stuttering with dominant stimulation, a larger unilateral (dominant) thalamic study can be undertaken. The magnitude of effect determined by this pilot trial will allow for a power calculation for the future study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults between the ages of 19 and 80 years old
- •Individuals with persistent PD stutter
Exclusion Criteria
- •Patients with mild symptoms.
- •Patients who have a neurodegenerative disease.
- •Patients with a bleeding diathesis.
- •non English speaking patients
Arms & Interventions
Deep Brain Simulation (DBS) System
The DBS device will be turned on to compare stutter to when the device was off (which would be the control).
Intervention: System ON (Device)
Deep Brain Simulation (DBS) System
The DBS device will be turned on to compare stutter to when the device was off (which would be the control).
Intervention: System OFF (Device)
Outcomes
Primary Outcomes
Change of One-Page Suttering Assessment from Baseline to Post-Operation
Time Frame: One-Page Stutter Assessment will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
Objectively assesses individual's stutter. Divide the number of instances of stuttering by the number of syllables in the sample and multiply by 100 to obtain the percentage of stuttered syllables.
Secondary Outcomes
- Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation(V-RQOL will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON)
- Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation(OASES will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON)
Investigators
Christopher Honey
Professor of Neurosurgery
University of British Columbia
