Deep Brain Stimulation + Therapy for Stroke

AB
CC
Overseen ByCierra Clark, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pirondini, Elvira, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

JG

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

Participants must be English speakers
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) showing Penetration-Aspiration-Scale (PAS) ≥ 2
I am between 22 and 75 years old.
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Exclusion Criteria

I do not have speech or swallowing problems from lower motor neuron lesions.
Participants must not have any serious disease or disorder (e.g., neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure) affecting study participation
Participants with language deficits (pure aphasia) and not speech deficits
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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

Group I: Rehabilitation Alone, then Combined with Deep Brain StimulationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pirondini, Elvira, PhD

Lead Sponsor