StrokeNCT07849114
Deep Brain Stimulation + Therapy for Stroke
A study testing Boston Scientific Vercise Deep Brain Stimulation (DBS) System and Rehabilitation Training Protocol in people with Stroke and Dysarthria, run by Pirondini, Elvira, PhD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and potential benefits of combining deep brain stimulation (DBS) with targeted speech and swallowing rehabilitation in individuals who have experienced a stroke and have moderate to severe difficulties with speech and/or swallowing. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Stroke, Dysarthria, Apraxia
- What is being tested?
- Boston Scientific Vercise Deep Brain Stimulation (DBS) System and Rehabilitation Training Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have suffered an ischemic or hemorrhagic stroke causing motor speech and swallowing deficits as a result. For ischemic stroke, the event needs to have occurred more than 6 months before the time of enrollment, whereas, for hemorrhagic stroke, the event needs to have occurred more than 12 months before the time of enrollment. Prior strokes that did not cause motor speech or swallowing deficits are not exclusionary.
- Participants must be between the ages of 22 and 75 years old.
- English speaker.
- Participants must have 30-84% intelligibility on the Speech Intelligibility Test (SIT), score ≤14 on the Communicative Participation Item Bank (CPIB) AND an instrumental swallowing assessment (VFSS or FEES) demonstrating Penetration-Aspiration-Scale (PAS) ≥ 2.
Who cannot join
- Participants must not have any serious disease or disorder (e.g., neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.
- Participants must not have a high risk of recurrent stroke as evident from their medical history or upon judgment of the study physician.
- Participants must not have a score on the Short Blessed Test assessment scale of ≥10.
- Female participants of child-bearing age must not be pregnant or breastfeeding during the study.
- Participants that cannot suspend their antiplatelets and/or anticoagulant therapy including aspirin, clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa) for two weeks around the surgery will be excluded from participation.
- Participants may not have any implanted medical device that is not MRI safe and must not have any active medical devices, including implanted stimulation devices, even if they are MRI safe.
Show all 13Show fewer
- Participants cannot have severe claustrophobia that can prevent them from executing the required MRI imaging sessions.
- Participants must not be taking oral or systemic anti-spasticity or anti-epileptic medications or facial and/or neck anti-spasticity injections (e.g., cosmetic Botox, migraine treatment, or bruxism/TMJ treatment) for 3 months prior to enrollment in the study and for the duration of the study. Participants may continue anti-spasticity injections localized to the upper- and/or lower-limbs.
- Participants with a T-score >63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator, and a study physician will be excluded from participation.
- Participants with gross anatomical variances in MR imaging or cerebral vascular accidents involving motor thalamus and cerebellar areas.
- Participants must not have any lesions in the lower motoneuron causing flaccid dysarthria and/or bulbar dysphagia.
- Participants with deficits affecting language (i.e., pure aphasia) and not speech deficits.
- Participants with diabetes mellitus whose recent Hemoglobin A1C value is 8.0% or greater.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Cierra Clark, MS, 2404414216, cic27@pitt.edu
Amy Boos, MS, 4126484179, amy.boos@pitt.edu
About this study
Official title: Deep Brain Stimulation of the Motor Thalamus Combined With Speech and Swallowing Therapy to Improve Post-Stroke Motor Speech and Swallowing Production Impairments
The purpose of this study is to evaluate the safety and potential benefits of combining deep brain stimulation (DBS) with targeted speech and swallowing rehabilitation in individuals who have experienced a stroke and have moderate to severe difficulties with speech and/or swallowing. Speech difficulties may include apraxia, which affects the ability to plan and coordinate speech movements, and dysarthria, which affects the ability to produce clear speech. Participants may also have difficulty swallowing (dysphagia).
The primary objective of this feasibility study is to evaluate the safety of the SR-DBS system in individuals with post-stroke speech and swallowing difficulties. The secondary objective is to evaluate whether combining DBS with speech and swallowing rehabilitation improves motor speech and swallowing function and reduces related impairments. The study will compare outcomes following rehabilitation alone with outcomes following rehabilitation combined with DBS to determine whether the addition of DBS provides greater improvements in speech and swallowing function.
Read the detailed description
The study will be conducted in three sequential phases. Following baseline assessments, participants will complete a structured speech and swallowing therapy program in Phase 1 (Rehabilitation), consisting of 60-minute sessions 3 days per week for 6 weeks, with 45 minutes dedicated to speech therapy and 15 minutes to swallowing therapy. In Phase 2 (Rehabilitation + DBS), participants will undergo implantation of the Stroke Rehabilitation Deep Brain Stimulation (SR-DBS) System and complete the same 6-week therapy program, with DBS delivered during the therapy sessions. Each session will include 45 minutes of speech therapy and 15 minutes of swallowing therapy. In Phase 3, implanted participants will be followed for 6 months after the intervention, with monthly laboratory visits to assess the effects of DBS on speech and swallowing function.
- Conditions
- Stroke, Dysarthria, Apraxia, Dysphagia, Hemiparesis After Stroke
- Being tested
- Boston Scientific Vercise Deep Brain Stimulation (DBS) System, Rehabilitation Training Protocol
- Keywords
- deep brain stimulation
- Medical subject headings
- Stroke, Dysarthria, Apraxias, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Vercise Deep Brain Stimulation (DBS) SystemDevice
The Vercise Genus R32 IPG (P150031 - S050) is a rechargeable implantable pulse generator designed to deliver electrical stimulation to the thalamus via two surgically implanted Vercise™ Cartesia™ X Directional Leads (16-contact), Model DB-2203 (P150031 - S065). The system will be used for the duration of Phases 2 and 3.
Rehabilitation Training ProtocolOther
The speech and swallowing training protocol (Rehab) is designed to engage with tailored exercises for speech and swallowing. For speech, the training exercises will be executed following the "Be Clear" program, which has been extensively validated in participants with non-progressive dysarthria and apraxia and has been recently shown to be effective also when administered through telemedicine. For swallowing, the training exercises will be based on the Intensive Dysphagia Rehabilitation protocol, developed for adults with neurogenic dysphagia.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Alone, then Combined with Deep Brain Stimulation | Experimental | Two Vercise™ Cartesia™ X Directional Leads (16-contact) - Model DB-2203 (P150031 - S065) will be surgically implanted bilaterally in the thalamus for the duration of Phases 2 and 3. The leads will be connected to a Vercise Genus R32 IPG (P150031 - S050), which will be surgically implanted in the chest and remain implanted for the duration of Phases 2 and 3. The IPG is rechargeable. Receives: Device: Boston Scientific Vercise Deep Brain Stimulation (DBS) System; Other: Rehabilitation Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Adverse Events
Success Criteria: No serious adverse events related to the stimulation or intolerable adverse events reported.
Measured: From enrollment to the end of treatment at 49 weeks
Secondary outcomes (7)
Absolute PAS Change - Phase 2
The investigators will measure the change in the Penetration Aspiration Scale (PAS) from post-implant to the end of Phase 2 with stimulation off. The PAS is an 8-point medical rating system used to describe how deep food, liquid, or saliva goes into a person's airway during a swallow. Scores range from 1 to 8, with lower scores indicating better swallowing function and higher scores indicating worse swallowing function. Success criteria: Mean change in PAS score across Phase 2 is greater than zero, indicating an additional therapeutic benefit of DBS beyond speech and swallowing training executed in Phase 1.
Measured: 11 weeks
Absolute PAS Change - Baseline to Phase 2
The investigators will measure the change in the Penetration Aspiration Scale (PAS) from baseline to the end of Phase 2 with stimulation off. The PAS is an 8-point medical rating system used to describe how deep food, liquid, or saliva goes into a person's airway during a swallow. Scores range from 1 to 8, with lower scores indicating better swallowing function and higher scores indicating worse swallowing function. Success criteria: Mean change in PAS score across the study period is greater than zero.
Measured: 19 weeks
Absolute Intelligibility - Phase 2
The investigators will measure the change in intelligibility from the Speech Intelligibility Test (SIT) from post-implant to the end of Phase 2 with stimulation off. The SIT is a clinical tool used to measure how clearly a person speaks and how well an unfamiliar listener can understand them. The SIT score ranges from 0% to 100%, with higher scores indicating better speech intelligibility and lower scores indicating worse speech intelligibility. It is calculated by counting the number of correct words, dividing that by the total number of words in the target stimulus, and multiplying that by 100 to calculate the percent-correct intelligibility score. Success criteria: Mean change in intelligibility across Phase 2 is greater than zero, indicating an additional therapeutic benefit of DBS beyond speech and swallowing training executed in Phase 1.
Measured: 11 weeks
Absolute Intelligibility - Baseline to Phase 2
The investigators will measure the change in intelligibility from the Speech Intelligibility Test (SIT) from baseline to the end of Phase 2 with stimulation off. The SIT is a clinical tool used to measure how clearly a person speaks and how well an unfamiliar listener can understand them. The SIT score ranges from 0% to 100%, with higher scores indicating better speech intelligibility and lower scores indicating worse speech intelligibility. It is calculated by counting the number of correct words, dividing that by the total number of words in the target stimulus, and multiplying that by 100 to calculate the percent-correct intelligibility score. Success criteria: Mean increase in intelligibility across the study period is equal or greater than 15 percentage points, indicating the average improvement surpasses the minimal clinically meaningful threshold.
Measured: 19 weeks
Modified Barium Swallow Impairment Profile Changes - Phase 2 to Phase 3
The investigators will measure changes in the Modified Barium Swallow Impairment Profile (MBSImP) scores with stimulation on and stimulation off during the same session. The MBSImP evaluates 17 distinct physiological components of swallowing, grouped into three main operational domains. Each component is rated on an ordinal impairment scale, with scores ranging from 0 (normal swallowing function) to 3 to 5 points depending on the specific physiological measure. Lower scores indicate less swallowing impairment and better swallowing function, while higher scores indicate greater swallowing impairment. Success criteria: 75% of participants will have significantly lower MBSImP scores with DBS ON compared to DBS OFF. This will confirm that DBS can immediately improve swallowing function.
Measured: 31 weeks
Motor Speech Function - Frenchay Dysarthria Assessment
The investigators will measure changes in Frenchay Dysarthria Assessment-Second Edition (FDA-2) scores with stimulation on and stimulation off during the same session. The FDA-2 uses a 9-point rating scale, ranging from 1 (severe impairment) to 9 (normal function), with higher scores indicating better motor speech function. Participants will complete either of the motor speech function assessments depending on the nature of their motor speech impairments (i.e., dysarthria vs. apraxia) as identified by a speech-language pathologist prior to speech and swallowing training in Phase 1. Participants with both dysarthria and apraxia will complete both assessments. Success criteria: 75% of participants will have significantly improved scores on the FDA-2 (i.e., higher score) with DBS ON compared to DBS OFF. This will confirm that DBS can immediately improve motor speech function.
Measured: 31 weeks
Motor Speech Function - Apraxia Battery for Adults
The investigators will measure changes in Apraxia Battery for Adults-Second Edition (ABA-2) scores with stimulation on and stimulation off during the same session. The ABA-2 assesses multiple aspects of motor speech and praxis, with subtest scores ranging from 0 to the maximum value specified for each subtest; higher or lower scores indicate better performance depending on the subtest. Participants will complete either of the motor speech function assessments depending on the nature of their motor speech impairments (i.e., dysarthria vs. apraxia) as identified by a speech-language pathologist prior to speech and swallowing training in Phase 1. Participants with both dysarthria and apraxia will complete both assessments. Success criteria: 75% of participants will have significantly improved scores on the ABA-2 (i.e., higher or lower score depending on the subsection) with DBS ON compared to DBS OFF. This will confirm that DBS can immediately improve motor speech function.
Measured: 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- This single-center, open-label, non-randomized, single-arm feasibility study will evaluate the safety and efficacy of the SR-DBS System when used in combination with speech and swallowing therapy to improve motor speech and swallowing function in individuals with post-stroke speech and swallowing impairments.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirondini, Elvira, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Gonzalez-Martinez, University of Pittsburgh
- Investigators
- Jorge Gonzalez-Martinez, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849114
- Sponsor's protocol ID
- STUDY26040015
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Motor Thalamus Combined With Speech and Swallowing Therapy to Improve Post-Stroke Motor Speech and Swallowing Production Impairments
- ClinicalTrials.gov ID
- NCT07849114
- Acronym / sponsor ID
- STUDY26040015
- Conditions
- Stroke, Dysarthria, Apraxia, Dysphagia, Hemiparesis After Stroke
- Keywords
- deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pirondini, Elvira, PhDUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 30 Sep 2026 (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 purpose of this study is to evaluate the safety and potential benefits of combining deep brain stimulation (DBS) with targeted speech and swallowing rehabilitation in individuals who have experienced a stroke and have moderate to severe difficulties with speech and/or swallowing. Speech difficulties may include apraxia, which affects the ability to plan and coordinate speech movements, and dysarthria, which affects the ability to produce clear speech. Participants may also have difficulty swallowing (dysphagia).
The primary objective of this feasibility study is to evaluate the safety of the SR-DBS system in individuals with post-stroke speech and swallowing difficulties. The secondary objective is to evaluate whether combining DBS with speech and swallowing rehabilitation improves motor speech and swallowing function and reduces related impairments. The study will compare outcomes following rehabilitation alone with outcomes following rehabilitation combined with DBS to determine whether the addition of DBS provides greater improvements in speech and swallowing function.
Detailed description
The study will be conducted in three sequential phases. Following baseline assessments, participants will complete a structured speech and swallowing therapy program in Phase 1 (Rehabilitation), consisting of 60-minute sessions 3 days per week for 6 weeks, with 45 minutes dedicated to speech therapy and 15 minutes to swallowing therapy. In Phase 2 (Rehabilitation + DBS), participants will undergo implantation of the Stroke Rehabilitation Deep Brain Stimulation (SR-DBS) System and complete the same 6-week therapy program, with DBS delivered during the therapy sessions. Each session will include 45 minutes of speech therapy and 15 minutes of swallowing therapy. In Phase 3, implanted participants will be followed for 6 months after the intervention, with monthly laboratory visits to assess the effects of DBS on speech and swallowing function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-center, open-label, non-randomized, single-arm feasibility study will evaluate the safety and efficacy of the SR-DBS System when used in combination with speech and swallowing therapy to improve motor speech and swallowing function in individuals with post-stroke speech and swallowing impairments.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Alone, then Combined with Deep Brain Stimulation | Experimental | Device: Boston Scientific Vercise Deep Brain Stimulation (DBS) System, Other: Rehabilitation Training ProtocolTwo Vercise™ Cartesia™ X Directional Leads (16-contact) - Model DB-2203 (P150031 - S065) will be surgically implanted bilaterally in the thalamus for the duration of Phases 2 and 3. The leads will be connected to a Vercise Genus R32 IPG (P150031 - S050), which will be surgically implanted in the chest and remain implanted for the duration of Phases 2 and 3. The IPG is rechargeable. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have suffered an ischemic or hemorrhagic stroke causing motor speech and swallowing deficits as a result. For ischemic stroke, the event needs to have occurred more than 6 months before the time of enrollment, whereas, for hemorrhagic stroke, the event needs to have occurred more than 12 months before the time of enrollment. Prior strokes that did not cause motor speech or swallowing deficits are not exclusionary.
- Participants must be between the ages of 22 and 75 years old.
- English speaker.
- Participants must have 30-84% intelligibility on the Speech Intelligibility Test (SIT), score ≤14 on the Communicative Participation Item Bank (CPIB) AND an instrumental swallowing assessment (VFSS or FEES) demonstrating Penetration-Aspiration-Scale (PAS) ≥ 2.
Key exclusion criteria (13 listed)
- Participants must not have any serious disease or disorder (e.g., neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.
- Participants must not have a high risk of recurrent stroke as evident from their medical history or upon judgment of the study physician.
- Participants must not have a score on the Short Blessed Test assessment scale of ≥10.
- Female participants of child-bearing age must not be pregnant or breastfeeding during the study.
- Participants that cannot suspend their antiplatelets and/or anticoagulant therapy including aspirin, clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa) for two weeks around the surgery will be excluded from participation.
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 |
|---|---|---|
| Boston Scientific Vercise Deep Brain Stimulation (DBS) SystemThe Vercise Genus R32 IPG (P150031 - S050) is a rechargeable implantable pulse generator designed to deliver electrical stimulation to the thalamus via two surgically implanted Vercise™ Cartesia™ X Directional Leads (16-contact), Model DB-2203 (P150031 - S065). The system will be used for the duration of Phases 2 and 3. | Device | Rehabilitation Alone, then Combined with Deep Brain Stimulation |
| Rehabilitation Training ProtocolThe speech and swallowing training protocol (Rehab) is designed to engage with tailored exercises for speech and swallowing. For speech, the training exercises will be executed following the "Be Clear" program, which has been extensively validated in participants with non-progressive dysarthria and apraxia and has been recently shown to be effective also when administered through telemedicine. For swallowing, the training exercises will be based on the Intensive Dysphagia Rehabilitation protocol, developed for adults with neurogenic dysphagia. | Other | Rehabilitation Alone, then Combined with Deep Brain Stimulation |
Primary outcome
Number and Severity of Adverse Events
Time frame: From enrollment to the end of treatment at 49 weeks
Success Criteria: No serious adverse events related to the stimulation or intolerable adverse events reported.
7 secondary outcomes
Absolute PAS Change - Phase 2
Time frame: 11 weeks
Absolute PAS Change - Baseline to Phase 2
Time frame: 19 weeks
Absolute Intelligibility - Phase 2
Time frame: 11 weeks
Absolute Intelligibility - Baseline to Phase 2
Time frame: 19 weeks
Modified Barium Swallow Impairment Profile Changes - Phase 2 to Phase 3
Time frame: 31 weeks
Motor Speech Function - Frenchay Dysarthria Assessment
Time frame: 31 weeks
Motor Speech Function - Apraxia Battery for Adults
Time frame: 31 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
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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.
Jorge Gonzalez-Martinez, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Vercise Deep Brain Stimulation (DBS) System and Rehabilitation Training Protocol in people with Stroke and Dysarthria, run by Pirondini, Elvira, PhD at 1 site in United States.
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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cierra Clark, MS (2404414216, cic27@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Severity of Adverse Events (time frame: From enrollment to the end of treatment at 49 weeks). 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 30 Sep 2026.