Parkinsonian Sutter

NCT06093399 | Unknown DMC

• 1 other identifier: H23-02962
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease Stutter

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Change of One-Page Suttering Assessment from Baseline to Post-Operation

  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.

  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

Secondary Outcomes (2)

• 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

Study Arms (1)

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).

Device: System ON; Device: System OFF

Interventions

System ON DEVICE

The DBS system will be turned on, and the individual's stutter will be assessed.

Deep Brain Simulation (DBS) System

System OFF DEVICE

The DBS system will be turned off, and the individual's stutter will be assessed.

Deep Brain Simulation (DBS) System

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 19 and 80 years old
• Individuals with persistent PD stutter

You may not qualify if:

• Patients with mild symptoms.
• Patients who have a neurodegenerative disease.
• Patients with a bleeding diathesis.
• non English speaking patients

Sponsors & Collaborators

• University of British Columbia: lead

Central Study Contacts

Danielle Pietramala

CONTACT

604-875-4111; danielle.pietram@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10