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Clinical Trials/NCT06093399
NCT06093399Not yet recruitingNot Applicable

Stimulation of the Thalamus to Ameliorate Parkinsonian Speech Disfluencies: Pilot Study

University of British Columbia0 sites3 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions

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

Experimental

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

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christopher Honey

Professor of Neurosurgery

University of British Columbia

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