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New treatment option for Stroke
Official title Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
ClinicalTrials.gov ID: NCT06303869
What this study is testing
- What it's testing
- The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a...
- Participants must be between the ages of 18 and 75 years old. (Participants outside this age range may be at an increased medical risk and have an...
- English speaker.
- Participant must score ≤ 80% in at least 4 categories of the perceptual speech assessment (speech intelligibility, listener effort, speech...
You likely can't join if
- Patients who refuse participation in the study.
- Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
- Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
- Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
- Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory...
- Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
See the full eligibility criteria
- Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a result.
- Participants must be between the ages of 18 and 75 years old. (Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing).
- English speaker.
- Participant must score ≤ 80% in at least 4 categories of the perceptual speech assessment (speech intelligibility, listener effort, speech naturalness, articulatory precision, speech rate, overall voice quality, and/or...
- Patients who refuse participation in the study.
- Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
- Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
- Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
- Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect...
- Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
- Participants must not be receiving anticoagulants.
- Severe claustrophobia.
- Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
- Participants who have been deemed inappropriate for participation based upon results from the Brief Symptoms Inventory (BSI-18) and discussions with the Principal Investigator and a study physician
- Evaluation to sign consent form score \<12.
- MRI contraindications (excluding people who are pregnant, who have metal in any portion of their body, have medical complications, cardiac pacemaker, cochlear implant, aneurysm clip, certain IUDs, or known problems of...
- Medications with common cognitive side-effects.
- Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).
- Patients must not have any lesions in the lower motoneuron causing flaccid dysarthria.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.