An interventional study of System On and System off in Persistent Developmental Stutter and Childhood-Onset Fluency Disorder (Stuttering), sponsored by University of British Columbia. Not yet recruiting. Open to participants aged 19 Years to 76 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's planned enrollment of 3 is below the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MRI Specific Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The DBS system will be turned on, and the individual's stutter will be assessed.
The DBS system will be turned off, and the individual's stutter will be assessed.
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.
Time frame: 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.
Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation
A 10-question, 5 point rating scale assessment, with higher scores reflecting a worse subjective voice-related quality of life.
Time frame: Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses quality of life post surgery.
Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation
5-point scale that indicates the amount of adverse impact a person experiences due to stuttering, with higher scores indicating higher levels of negative impact.
Time frame: Baseline assessment will be done pre-operatively. Four weeks after device programming, the patients will attend the DBS clinic with bilateral electrodes on to asses subjective voice experience post surgery.
No study locations are listed for this record.
Start is estimated for Nov 2023; primary completion for Nov 2024, 12 months later.
Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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