Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

Launched by JORGE GONZALEZ-MARTINEZ · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether deep brain stimulation (DBS) can help improve hand and arm movement as well as speech for people who have experienced a stroke. The researchers want to see if this treatment can make a positive difference in daily activities and overall quality of life for those affected by a stroke. Participants will have a small surgery to place electrodes in their brain, which will be connected to devices that send electrical signals. After less than 30 days, the electrodes will be removed. The findings from this study could lead to new ways to help patients regain their abilities after a stroke.

To be eligible for this trial, participants should be between 18 and 75 years old and have had a stroke more than six months ago, resulting in speech difficulties known as dysarthria. They also need to be native English speakers and have moderate to severe trouble being understood when they speak. Participants can expect to undergo some tests and evaluations during the study to see how their movements and speech improve with the stimulation. It’s important to note that there are specific medical conditions and treatments that could prevent someone from joining, so a thorough screening will be done to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a result.
• • 2. 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).
• • 3. English speaker.
• • 4. 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 overall speech severity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.
• Exclusion Criteria:
• • 1. Patients who refuse participation in the study.
• • 2. Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
• • 3. Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
• • 4. Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
• • 5. 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 their ability to participate in this study.
• • 6. Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
• • 7. Participants must not be receiving anticoagulants.
• • 8. Severe claustrophobia.
• • 9. Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
• • 10. 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
• • 11. Evaluation to sign consent form score \<12.
• • 12. MRI contraindications (excluding subjects 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 claustrophobia).
• • 13. Medications with common cognitive side-effects.
• • 14. Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).
• • 15. Patients must not have any lesions in the lower motoneuron causing flaccid dysarthria.