Deep Brain Stimulation + Therapy for Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorPirondini, Elvira, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Boston Scientific Vercise Deep Brain Stimulation (DBS) System
DeviceThe 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 Protocol
Other interventionThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Rehabilitation Alone, then Combined with Deep Brain StimulationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number and Severity of Adverse Events
Success Criteria: No serious adverse events related to the stimulation or intolerable adverse events reported.
Time frame
From enrollment to the end of treatment at 49 weeksSecondary outcomes
1
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.
Time frame
11 weeks2
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.
Time frame
19 weeks3
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.
Time frame
11 weeks4
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.
Time frame
19 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pirondini, Elvira, PhD
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov
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