Stimulation of the Thalamus to Ameliorate Persistent Disfluency

Childhood-Onset Fluency Disorder (Stuttering) Clinical Trial

— SToPeD  

Official title:

Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641701
• Other study ID #: H22-02984
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: October 2023
• Source: University of British Columbia
• Contact: Danielle Pietramala
• Phone: 604-875-4111
• Email: danielle.pietram[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood-Onset Fluency Disorder
• Childhood-Onset Fluency Disorder (Stuttering)
• Stuttering

Intervention

Device:
• System On
The DBS system will be turned on, and the individual's stutter will be assessed.
• System off
The DBS system will be turned off, and the individual's stutter will be assessed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Secondary	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.	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.
Secondary	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.	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.