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Deep Brain Stimulation + Therapy for Stroke

23. september 2026 opdateret af: Jorge Gonzalez-Martinez, Pirondini, Elvira, PhD

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Cierra Clark, MS
  • Telefonnummer: 2404414216
  • E-mail: cic27@pitt.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
        • Ledende efterforsker:
          • Jorge Gonzalez-Martinez, MD, PhD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

22 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. Participants must be between the ages of 22 and 75 years old.
  3. English speaker.
  4. 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.

Exclusion Criteria:

  1. 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.
  2. Participants must not have a high risk of recurrent stroke as evident from their medical history or upon judgment of the study physician.
  3. Participants must not have a score on the Short Blessed Test assessment scale of ≥10.
  4. Female participants of child-bearing age must not be pregnant or breastfeeding during the study.
  5. 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.
  6. 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.
  7. Participants cannot have severe claustrophobia that can prevent them from executing the required MRI imaging sessions.
  8. 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.
  9. 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.
  10. Participants with gross anatomical variances in MR imaging or cerebral vascular accidents involving motor thalamus and cerebellar areas.
  11. Participants must not have any lesions in the lower motoneuron causing flaccid dysarthria and/or bulbar dysphagia.
  12. Participants with deficits affecting language (i.e., pure aphasia) and not speech deficits.
  13. Participants with diabetes mellitus whose recent Hemoglobin A1C value is 8.0% or greater.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rehabilitation Alone, then Combined with Deep Brain Stimulation

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.
Enhed: Boston Scientific Vercise Deep Brain Stimulation (DBS) System

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.

Andet: Rehabilitation Training Protocol

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and Severity of Adverse Events
Tidsramme: 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.
From enrollment to the end of treatment at 49 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute PAS Change - Phase 2
Tidsramme: 11 weeks

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.
11 weeks
Absolute PAS Change - Baseline to Phase 2
Tidsramme: 19 weeks

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.
19 weeks
Absolute Intelligibility - Phase 2
Tidsramme: 11 weeks

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.
11 weeks
Absolute Intelligibility - Baseline to Phase 2
Tidsramme: 19 weeks

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.
19 weeks
Modified Barium Swallow Impairment Profile Changes - Phase 2 to Phase 3
Tidsramme: 31 weeks

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.
31 weeks
Motor Speech Function - Frenchay Dysarthria Assessment
Tidsramme: 31 weeks

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.
31 weeks
Motor Speech Function - Apraxia Battery for Adults
Tidsramme: 31 weeks

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.
31 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pirondini, Elvira, PhD

Efterforskere

  • Ledende efterforsker: Jorge Gonzalez-Martinez, MD, PhD, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. juli 2030

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

16. september 2026

Først indsendt, der opfyldte QC-kriterier

23. september 2026

Først opslået (Faktiske)

30. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY26040015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 2 years from enrollment of first participant.

IPD-delingsadgangskriterier

Data must be directly requested to the PI and will be shared upon completion of necessary data sharing agreement to protect confidential patient information.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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