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NOT YET RECRUITING

NCT07849114

Deep Brain Stimulation + Therapy for Stroke

Sponsor: Pirondini, Elvira, PhD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01

Completion Date

2030-07

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Stroke Dysarthria Apraxia Dysphagia Hemiparesis After Stroke

Interventions

DEVICE

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.

OTHER

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.

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.

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States