Stimulation of the Thalamus to Ameliorate Persistent Disfluency (NCT05641701) | Clinical Trial Compass
UnknownNot Applicable
Stimulation of the Thalamus to Ameliorate Persistent Disfluency
3 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
19 Years – 76 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults between the ages of 19 and 76 years old
* Individuals 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of One-Page Suttering Assessment from Baseline to Post-Operation
Timeframe: Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic for 1-page stutter assessment with bilateral electrodes on.