Fact CheckerSign in

NCT06303869Recruiting

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

Source: ClinicalTrials.gov · Last updated 8 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
4 Mar 2024
Start date
20 Jun 2025
Primary completion date
Nov 2027
Lead sponsor
Jorge Gonzalez-Martinez
Diseases
Stroke
NCT number
NCT06303869

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 20 Jun 2025 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not be receiving anticoagulants.
  • Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
  • Medications with common cognitive side-effects.

Other illness

  • Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
  • 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.
  • 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).

Lab values

  • Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).

Age

  • Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.

Other

  • 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 who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
  • Severe claustrophobia.
  • 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.
  • Patients must not have any lesions in the lower motoneuron causing flaccid dysarthria.

Who the study is looking for

  • 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 overall speech severity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pittsburgh
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.