Deep Brain Stimulation + Therapy for Stroke
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Jorge Gonzalez-Martinez, MD, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults who have had a stroke and now have moderate to severe problems with speech or swallowing, such as trouble speaking clearly (dysarthria), planning speech movements (apraxia), or difficulty swallowing. Participants must be able to take part in rehabilitation therapy.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Boston Scientific Vercise Deep Brain Stimulation (DBS) System
Trial Overview
The study compares two approaches: standard speech and swallowing rehabilitation alone versus the same rehab combined with deep brain stimulation using the Boston Scientific Vercise DBS system. The goal is to see if adding DBS improves recovery after stroke.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pirondini, Elvira, PhD
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.