Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06303869

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

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

10

Participants Needed

1

Research Sites

232 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 resulting speech difficulties (dysarthria).
  • Participants must be between 18 and 75 years old.
  • Participants must speak English.
  • Participants must score 80% or less in at least 4 categories of speech assessment or 80% or less in 3 categories plus 27 or less on the Communicative Participation Item Bank.
Not Eligible

You will not qualify if you...

  • Patients who refuse to participate.
  • Patients with major brain anatomical abnormalities or strokes involving thalamic and cerebellar areas.
  • Patients not suitable for DBS surgery or highly dependent on anticoagulation therapy.
  • Patients unable to undergo pre-operative MRI or assessments.
  • Patients with serious diseases or cognitive impairments affecting participation.
  • Female participants of child-bearing age who are pregnant, planning pregnancy within 9 months, or breastfeeding.
  • Patients currently taking anticoagulants.
  • Patients with severe claustrophobia.
  • Patients currently on anti-spasticity or anti-epileptic medications.
  • Patients deemed unsuitable based on psychological evaluation.
  • Patients unable to provide informed consent.
  • Patients with MRI contraindications such as metal implants, pacemakers, cochlear implants, aneurysm clips, certain IUDs, or claustrophobia.
  • Patients taking medications with cognitive side effects.
  • Patients with bleeding disorders or platelet dysfunction.
  • Patients with lesions causing flaccid dysarthria due to lower motoneuron damage.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

E

Elvira Pirondini, PhD

CONTACT

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