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

Last updated: June 25, 2025
Sponsor: Jorge Gonzalez-Martinez
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Stroke

Cerebral Ischemia

Treatment

Deep Brain Stimulation (DBS) of the Motor Thalamus

Clinical Study ID

NCT06303869
STUDY22070043
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 outsidethis age range may be at an increased medical risk and have an increased risk offatigue during testing).

  3. English speaker.

  4. Participant must score ≤ 80% in at least 4 categories of the perceptual speechassessment (speech intelligibility, listener effort, speech naturalness,articulatory precision, speech rate, overall voice quality, and/or overall speechseverity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.

Exclusion

Exclusion Criteria:

  1. Patients who refuse participation in the study.

  2. Patients with gross anatomical variances in MR imaging or cerebral vascularaccidents involving thalamic and cerebellar areas.

  3. Patients with no clinical condition to undergo DBS implantation or highly dependenton anticoagulation therapy.

  4. Patients who cannot undergo pre-operative MRIs or could not complete thepre-operative assessments.

  5. Participants must not have any serious disease or disorder (ex. neurologicalcondition other than stroke, cancer, severe cardiac or respiratory disease, renalfailure, etc.) or cognitive impairments that could affect their ability toparticipate in this study.

  6. Female participants of child-bearing age must not be pregnant, planning to becomepregnant 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 theduration of the study.

  10. Participants who have been deemed inappropriate for participation based upon resultsfrom the Brief Symptoms Inventory (BSI-18) and discussions with the PrincipalInvestigator and a study physician

  11. Evaluation to sign consent form score <12.

  12. MRI contraindications (excluding subjects who are pregnant, who have metal in anyportion of their body, have medical complications, cardiac pacemaker, cochlearimplant, 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 flacciddysarthria.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation (DBS) of the Motor Thalamus
Phase:
Study Start date:
June 20, 2025
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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