Using deep brain stimulation to improve speech and arm function after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine if deep brain stimulation (DBS) can enhance motor function in the hand and arm, as well as speech abilities, in individuals who have experienced a subcortical stroke. Participants will undergo a surgical procedure to implant DBS electrodes, which will be connected to external stimulators. The study will assess the immediate effects of stimulation on muscle recruitment and the potential long-lasting benefits once stimulation is turned off. The findings will help lay the groundwork for future neuro-rehabilitation strategies aimed at restoring independence and quality of life for stroke survivors.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jorge Gonzalez-Martinez, MD/PhD — University of Pittsburgh
• Study coordinator: Cierra Clark, MS
• Email: cic27@pitt.edu
• Phone: 240-441-4216

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.