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Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study
Persistent developmental stutter / childhood onset fluency disorder is a disabling condition leading to significant communication and psychological disability. Established treatment consists of intensive speech therapy, and whilst initially effective, has a waning long-term benefit. Our research team aims to provide evidence of stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation. The investigators propose to perform bilateral DBS on 3 participants with stutter refractory to intensive speech therapy, to determine a response in their stutter. The assessments will be double-blinded. The investigators will use the outcome of this small pilot study to determine the feasibility and details of a larger randomized controlled trial.
Suitable participants are referred by speech pathology centers, after having failed an intensive speech therapy program. Referred participants are contacted by the Neurosurgery DBS Clinic, and assessed for suitability and willingness to participate. These potential participants will be contacted by the DBS Clinic at Vancouver General Hospital to discuss the scope of the study, and educate them about deep brain stimulation. Those who wish to be included in the study will attend a face-to-face appointment at the DBS Clinic. At the initial appointment, informed consent will take place. Baseline assessments will be undertaken, including the Overall Assessment of the Speaker's Experience of Stuttering (OASES), Voice-related Quality of Life (VRQoL), and "The One Page Stuttering Assessment". The participants will be referred for a functional MRI for mapping of speech and language laterality. The participants will then undergo surgery for implantation of a bilateral thalamic DBS system. They will stay overnight in the hospital, and have a post-operative CT scan on the first post-operative day. This scan will be used to assess accuracy of electrode placement, as per usual technique. 4 weeks post-operatively, the participants will attend the DBS Clinic for programming of their devices. 4 weeks after device programming, the participants will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on, bilateral electrodes off, left electrode on, and right electrode on, as well as OASES and VRQoL. The scores from the 1-page stutter assessment, as well as pre- and post-operative OASES and VRQoL, will be compared via the Wilcoxan rank sum test for nonparametric repeated measures.
Age
19 - 76 years
Sex
ALL
Healthy Volunteers
No
Start Date
November 1, 2023
Primary Completion Date
November 15, 2024
Completion Date
November 15, 2024
Last Updated
October 12, 2023
3
ESTIMATED participants
System On
DEVICE
System off
DEVICE
Christopher R Honey
CONTACT
Lead Sponsor
University of British Columbia
NCT04173949
NCT04492956
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00239915