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Not Yet Recruiting NCT05641701

Stimulation of the Thalamus to Ameliorate Persistent Disfluency

Conditions: Persistent Developmental Stutter, Childhood-Onset Fluency Disorder (Stuttering)

Sex: All
Ages: 19 Years – 76 Years
Phase: NA
Enrollment: 3
Sponsor: University of British Columbia

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 patients with stutter refractory to intensive speech therapy, to determine a response in their stutter. The assessments will be double-blinded. We will use the outcome of this small pilot study to determine the feasibility and details of a larger randomized controlled trial.

Eligibility Criteria

Inclusion Criteria:Adults between the ages of 19 and 76 years oldIndividuals with persistent developmental stutter refractory to intensive speech therapy, as diagnosed by a speech and language therapist.Exclusion Criteria:Children and adolescents will not be included, as there is a significant percentage of developmental stuttering that will spontaneously resolve in this age group.Patients who have not trialed standard therapy will not be included in this study.Patients with mild symptoms.Patients who have a neurodegenerative disease.Patients with a bleeding diathesis.Patients who are unable to communicate.MRI Specific Exclusion criteria:Patients with a cardiac pacemaker or defibrillator.Patient with an insulin or infusion pump.Patients with a cochlear, otologic, or ear implant.Patients with an implant held in place by a magnet.Patients with tissue expanders.Patients with implanted clips, catheters, clamps, valves, or other metal.Patients with tattoos or permanent makeup above shoulders.Patients with shrapnel or other retained metal.Patients who are pregnant.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05641701). StuddyBuddy aggregates publicly available trial information.