Deep brain stimulation with speech and swallowing therapy after stroke
Tests deep brain stimulation plus therapy for speech and swallowing problems after stroke.
Plain-language title generated from the registry record
Registry title: Deep Brain Stimulation + Therapy for Stroke
Key facts
- Where
- Pittsburgh, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT07849114, who can take part
Where in United States
- University of PittsburghPittsburgh, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pirondini, Elvira, PhD
- Trial code
- NCT07849114
- Record updated
- 30 September 2026
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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 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 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 with diabetes mellitus whose recent Hemoglobin A1C value is 8.0% or greater; Female participants of child-bearing age must not be pregnant or breastfeeding during the study; Participants must not have a score on the Short Blessed Test assessment scale of ≥10; 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 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.