NCT05641701

Stimulation of the Thalamus to Ameliorate Persistent Disfluency

Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Persistent Developmental Stutter
• Childhood-Onset Fluency Disorder (Stuttering)

Interventions

Type	Name	Description
DEVICE	System On	The DBS system will be turned on, and the individual's stutter will be assessed.
DEVICE	System off	The DBS system will be turned off, and the individual's stutter will be assessed.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2022-12-08
• Last updated: 2023-10-12