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NCT06303869 | RECRUITING | Stroke

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

Jorge Gonzalez-Martinez

Information provided by (Responsible Party):

Jorge Gonzalez-Martinez

Brief Summary:

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. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.

Condition or disease

Stroke

Brain Disease

Central Nervous System Diseases

Nervous System Diseases

Cardiovascular Diseases

Intervention/treatment

Deep Brain Stimulation (DBS) of the Motor Thalamus

Phase

NA

Detailed Description:

The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit face muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2027-11
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

Location Details

NCT06303869

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213