Deep Brain Stimulation + Therapy for Stroke

NCT07849114 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY26040015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Dysarthria; Apraxia; Dysphagia; Hemiparesis After Stroke

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Number and Severity of Adverse Events

  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

Secondary Outcomes (7)

• Absolute PAS Change - Phase 2

  11 weeks

• Absolute PAS Change - Baseline to Phase 2

  19 weeks

• Absolute Intelligibility - Phase 2

  11 weeks

• Absolute Intelligibility - Baseline to Phase 2

  19 weeks

• Modified Barium Swallow Impairment Profile Changes - Phase 2 to Phase 3

  31 weeks

Study Arms (1)

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.

Device: Boston Scientific Vercise Deep Brain Stimulation (DBS) System; Other: Rehabilitation Training Protocol

Interventions

Boston Scientific Vercise Deep Brain Stimulation (DBS) System DEVICE

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 Alone, then Combined with Deep Brain Stimulation

Rehabilitation Training Protocol OTHER

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.

Rehabilitation Alone, then Combined with Deep Brain Stimulation

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pirondini, Elvira, PhD: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Stroke; Dysarthria; Apraxias; Deglutition Disorders

Interventions

Deep Brain Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative; Drug Therapy

Study Officials

• Jorge Gonzalez-Martinez, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cierra Clark, MS

CONTACT

2404414216; cic27@pitt.edu

Amy Boos, MS

CONTACT

412-648-4179; amyy.boos@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: Data must be directly requested to the PI and will be shared upon completion of necessary data sharing agreement to protect confidential patient information.

Locations

US (1)