Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06303869

Deep Brain Stimulation of Motor Thalamus for Speech and Upper-Limb Function Restoration in People With Subcortical Stroke

Led by Jorge Gonzalez-Martinez · Updated on 2026-05-08

10

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of deep brain stimulation (DBS) to improve hand and arm motor function and speech abilities in people who have had a stroke. This study focuses on participants with subcortical strokes who experience speech and motor deficits. It aims to understand both the immediate effects of DBS when the stimulation is active and potential therapeutic effects lasting after stimulation is turned off, providing a foundation for future neuro-rehabilitation programs. Participants will undergo a surgical procedure to implant DBS electrode leads in the motor thalamus area of the brain. These electrodes will be connected to external stimulators, and various experiments will test how stimulation affects movements of the face, hand, and arm, as well as speech abilities. The implanted device will be removed within 30 days after implantation. Throughout the study, participants will be closely monitored for adverse events, discomfort, and pain at baseline, 2 weeks, 4 weeks, and 6 months. Researchers will assess speech, hand dexterity, muscle weakness, spasticity, and range of motion. The study includes detailed clinical measures to evaluate changes during and after stimulation, with a total participation period that includes surgical implantation, stimulation testing, and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have had a single ischemic or hemorrhagic stroke more than 6 months before enrollment with speech difficulties (dysarthria).
  • Age between 18 and 75 years.
  • Must be English speaking.
  • Must meet specific speech assessment criteria: score 80% or less in at least 4 categories of perceptual speech assessment OR 80% or less in at least 3 categories plus a score of 27 or less on the Communicative Participation Item Bank.
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study.
  • Anatomical abnormalities in MRI or strokes involving thalamic and cerebellar areas.
  • Not suitable for DBS implantation or highly dependent on anticoagulation therapy.
  • Unable to undergo pre-operative MRI or complete pre-operative assessments.
  • Presence of serious diseases or cognitive impairments affecting study participation.
  • Pregnancy, planning pregnancy within 9 months, or breastfeeding for females of child-bearing age.
  • Current use of anticoagulants.
  • Severe claustrophobia.
  • Use of anti-spasticity or anti-epileptic medications during the study.
  • Deemed inappropriate based on psychological evaluation.
  • Inability to provide informed consent.
  • MRI contraindications such as metal implants, pacemakers, cochlear implants, aneurysm clips, certain IUDs, or claustrophobia.
  • Use of medications with common cognitive side effects.
  • Bleeding disorders or platelet dysfunction.
  • Lesions causing flaccid dysarthria from lower motoneuron damage.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Less than 30 days

Participants undergo a surgical procedure to implant deep brain stimulation electrode leads connected to external stimulators. Initial experiments are performed to identify movements and speech effects with stimulation.

Multiple visits during hospitalization and post-operative period

Post-operative Follow-up

Duration - Up to 6 months

Participants are monitored after the implant is removed to assess discomfort, pain, and motor and speech functions.

Visits at baseline, 2 weeks, 4 weeks, and 6 months

Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

C

Cierra Clark, MS

E

Elvira Pirondini, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Published Research Related To This Trial

Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man.

I S Cooper, A R Upton, I Amin

https://pubmed.ncbi.nlm.nih.gov/6975064

Long-term chronic stimulation of internal capsule in poststroke pain and spasticity. Case report, long-term results and review of the literature.

Angelo Franzini, Roberto Cordella, Vittoria Nazzi...

https://pubmed.ncbi.nlm.nih.gov/18334861