Parkinson's Disease StutterNCT06093399
Parkinsonian Sutter
A study testing System ON and System OFF in people with Parkinson's Disease Stutter, run by University of British Columbia.
Trial summary
The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Parkinson's Disease Stutter
- 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
- Dec 2023to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 19 and 80 years old
- Individuals with persistent PD stutter
Who cannot join
- Patients with mild symptoms.
- Patients who have a neurodegenerative disease.
- Patients with a bleeding diathesis.
- non English speaking patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stimulation of the Thalamus to Ameliorate Parkinsonian Speech Disfluencies: Pilot Study
The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). The team proposes to perform unilateral DBS on 3 patients with PD stutter refractory to intensive speech therapy, to determine a response in their PD stutter. The assessments will be double-blinded. The investigators will use the outcome of this case series to determine the feasibility and details of a larger randomized controlled trial.
Read the detailed description
Purpose: The purpose is to assess if dominant thalamic Deep Brain Stimulation (DBS) is an effective treatment for Parkinsonian stutter. Functional magnetic resonance imaging (MRI) will detect brain dominance before surgery. The research team will assess whether dominant thalamic DBS is preferable for stutter treatment.
Hypothesis: The research team hypothesizes that dominant thalamic neuromodulation with DBS effectively treats PD stutter.
Justification:
The investigators initially began investigating the possibility of treatment of Stutter with DBS when they had a patient whose stutter serendipitously improved following thalamic DBS for tremor. The patient had severe tremor requiring bilateral thalamic DBS; he coincidentally had stutter. Post-operatively, the patient noted that he had had marked improvement in his tremor as well as his stutter. This prompted a literature search, where the investigators found that this has previously been reported in one other patient. Previous investigations of spasmodic dysphonia show that speech (similar to language) is lateralized in most patients, and that unilateral treatment of the dominant hemisphere is as beneficial as bilateral treatment.
Objectives: The objective is to perform a case series of three patients to assess feasibility and determine design of a future, larger study. If there is an appreciable reduction in stuttering with dominant stimulation, a larger unilateral (dominant) thalamic study can be undertaken. The magnitude of effect determined by this pilot trial will allow for a power calculation for the future study.
Research Design:
Pre-operatively, patients will complete "The One Page Stuttering Assessment," Overall Assessment of the Speaker's Experience of Stuttering (OASES), Voice-related Quality of Life (VRQoL), Beck Depression Inventory version II (BDI-II), and Montreal Cognitive Assessment (MoCA). Patients will then have a functional MRI scan and unilateral thalamic DBS systems implanted. The patient will be randomized to either the DBS on or DBS off group and complete the "One Page Stutter Assessment," OASES and VRQoL on both settings. After 6 months, an unblinded phase follows until the end of the study 12 months after surgery. At the end of the 12 month post-op, participants will complete the OASES, VRQoL, "One Page Stutter Assessment," MoCA and BDI-II.
Statistical Analysis: The primary outcome will be PD stutter severity, as assessed by the One-Page Sutter Assessment. Outcomes will be statistically compared by a Wilcoxon analysis for paired nonparametric measures with a significance set at P<0.05. Secondary outcomes will be the quality of life measures, Voice Related Quality of Life (VRQoL) and Overall Assessment of the Speaker's Experience of Stuttering (OASES), as well as the Montreal Cognitive Assessment (MoCA), and Beck Depression Inventory version II (BDI-II).
- Conditions
- Parkinson's Disease Stutter
- Being tested
- System ON, System OFF
- Keywords
- Deep Brain Stimulation
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: One-Page Stutter Assessment will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-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: V-RQOL will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
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: OASES will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease 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
- NCT06093399
- Sponsor's protocol ID
- H23-02962
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the Thalamus to Ameliorate Parkinsonian Speech Disfluencies: Pilot Study
- ClinicalTrials.gov ID
- NCT06093399
- Acronym / sponsor ID
- H23-02962
- Conditions
- Parkinson's Disease Stutter
- 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
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
The research team aims to provide evidence of Parkinsonian (PD) Stutter management by addressing the primary neurological issue in this disorder using Deep Brain Stimulation (DBS). The team proposes to perform unilateral DBS on 3 patients with PD stutter refractory to intensive speech therapy, to determine a response in their PD stutter. The assessments will be double-blinded. The investigators will use the outcome of this case series to determine the feasibility and details of a larger randomized controlled trial.
Detailed description
Purpose: The purpose is to assess if dominant thalamic Deep Brain Stimulation (DBS) is an effective treatment for Parkinsonian stutter. Functional magnetic resonance imaging (MRI) will detect brain dominance before surgery. The research team will assess whether dominant thalamic DBS is preferable for stutter treatment.
Hypothesis: The research team hypothesizes that dominant thalamic neuromodulation with DBS effectively treats PD stutter.
Justification:
The investigators initially began investigating the possibility of treatment of Stutter with DBS when they had a patient whose stutter serendipitously improved following thalamic DBS for tremor. The patient had severe tremor requiring bilateral thalamic DBS; he coincidentally had stutter. Post-operatively, the patient noted that he had had marked improvement in his tremor as well as his stutter. This prompted a literature search, where the investigators found that this has previously been reported in one other patient. Previous investigations of spasmodic dysphonia show that speech (similar to language) is lateralized in most patients, and that unilateral treatment of the dominant hemisphere is as beneficial as bilateral treatment.
Objectives: The objective is to perform a case series of three patients to assess feasibility and determine design of a future, larger study. If there is an appreciable reduction in stuttering with dominant stimulation, a larger unilateral (dominant) thalamic study can be undertaken. The magnitude of effect determined by this pilot trial will allow for a power calculation for the future study.
Research Design:
Pre-operatively, patients will complete "The One Page Stuttering Assessment," Overall Assessment of the Speaker's Experience of Stuttering (OASES), Voice-related Quality of Life (VRQoL), Beck Depression Inventory version II (BDI-II), and Montreal Cognitive Assessment (MoCA). Patients will then have a functional MRI scan and unilateral thalamic DBS systems implanted. The patient will be randomized to either the DBS on or DBS off group and complete the "One Page Stutter Assessment," OASES and VRQoL on both settings. After 6 months, an unblinded phase follows until the end of the study 12 months after surgery. At the end of the 12 month post-op, participants will complete the OASES, VRQoL, "One Page Stutter Assessment," MoCA and BDI-II.
Statistical Analysis: The primary outcome will be PD stutter severity, as assessed by the One-Page Sutter Assessment. Outcomes will be statistically compared by a Wilcoxon analysis for paired nonparametric measures with a significance set at P<0.05. Secondary outcomes will be the quality of life measures, Voice Related Quality of Life (VRQoL) and Overall Assessment of the Speaker's Experience of Stuttering (OASES), as well as the Montreal Cognitive Assessment (MoCA), and Beck Depression Inventory version II (BDI-II).
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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between the ages of 19 and 80 years old
- Individuals with persistent PD stutter
Key exclusion criteria (4 listed)
- Patients with mild symptoms.
- Patients who have a neurodegenerative disease.
- Patients with a bleeding diathesis.
- non English speaking patients
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: One-Page Stutter Assessment will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-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: V-RQOL will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
Change of Overall Assessment of the Speaker's Experience of Stuttering (OASES) from Baseline to Post-Operation
Time frame: OASES will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-ON
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Related trials for Parkinson's Disease Stutter
Recruiting
Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
Parkinson's Disease (PD), Essential Tremor
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.
Questions about this trial
What is this clinical trial studying?
A study testing System ON and System OFF in people with Parkinson's Disease Stutter, 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 4 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 23 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: One-Page Stutter Assessment will be reported by the patients preoperatively, after three months of blinded DBS-ON and DBS-OFF, and then again after 6 months unblinded DBS-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 23 Oct 2023.