Persistent Developmental StutterSToPeDNCT05641701
Stimulation of the Thalamus to Ameliorate Persistent Disfluency
A study testing System On and System off in people with Persistent Developmental Stutter and Childhood-Onset Fluency Disorder (Stuttering), run by University of British Columbia.
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. Read more about this study
- Who is it for?
- Ages 19 to 76 years
- Conditions the study is for
- Persistent Developmental Stutter, Childhood-Onset Fluency Disorder (Stuttering)
- What is being tested?
- System On and System off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
Christopher R Honey contact
About this study
Official title: Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study
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.
Read the 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.
- Being tested
- System On, System off
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Childhood-Onset Fluency Disorder, Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System OnDevice
The DBS system will be turned on, and the individual's stutter will be assessed.
System offDevice
The DBS system will be turned off, and the individual's stutter will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Simulation (DBS) System | Experimental | The DBS device will be turned on to compare stutter to when the device was off (which would be the control). Receives: Device: System On; Device: System off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Nov 2023 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Developmental StutterStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641701
- Sponsor's protocol ID
- H22-02984
- Acronym
- SToPeD
- Status last verified
- Oct 2023
- First submitted
- 23 Nov 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the Thalamus to Ameliorate Persistent Disfluency: Pilot Study
- ClinicalTrials.gov ID
- NCT05641701
- Acronym / sponsor ID
- SToPeD / H22-02984
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will act as their own control. Each individual's stutter will be assessed with DBS system OFF (control) and DBS ON (treatment).
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Simulation (DBS) System | Experimental | Device: System On, Device: System offThe DBS device will be turned on to compare stutter to when the device was off (which would be the control). |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| System OnThe DBS system will be turned on, and the individual's stutter will be assessed. | Device | Deep Brain Simulation (DBS) System |
| System offThe DBS system will be turned off, and the individual's stutter will be assessed. | Device | Deep Brain Simulation (DBS) System |
Primary outcome
Change of One-Page Suttering Assessment from Baseline to Post-Operation
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.
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.
2 secondary outcomes
Change of Voice Related Quality of Life (VRQoL) from Baseline to Post-Operation
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R Honey contact
Questions about this trial
What is this clinical trial studying?
A study testing System On and System off in people with Persistent Developmental Stutter and Childhood-Onset Fluency Disorder (Stuttering), run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Pietramala (604-875-4111 ext. 68396, danielle.pietram@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of One-Page Suttering Assessment from Baseline to Post-Operation (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.