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

NCT06303869 | Recruiting DMC FDA Device

• 1 other identifier: STUDY22070043
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Disease; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The investigators will quantify the safety of DBS to treat post-stroke speech and upper-limb motor deficits. For this, the investigators will record all adverse events for the entire study duration. The study is considered successful if no serious adverse events related to the use of deep brain stimulation are reported.

  29 days

• Discomfort and Pain

  The investigators will assess the relative level of discomfort and/or pain that is associated with the delivery of electrical stimulation to the motor thalamus. After each stimulation train patients will be asked to report a level of perceived discomfort using a 10 value subjective scale. Low values will be assigned to low discomfort and high values to high discomfort. The study is considered successful if 70% of recruited subjects do not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the face and upper-limb muscles.

  Baseline, 2 weeks, 4 weeks, 6 months.

Secondary Outcomes (8)

• Dysphagia

  29 days

• Hand dexterity

  29 days.

• Muscle weakness

  29 days

• Dexterity of Articulation AMRs

  29 days

• Dexterity of Articulation SMRs

  29 days

Study Arms (1)

Deep Brain Stimulation of the Motor Thalamus

EXPERIMENTAL

Individuals who have speech and motor deficits due to a stroke.

Device: Deep Brain Stimulation (DBS) of the Motor Thalamus

Interventions

Deep Brain Stimulation (DBS) of the Motor Thalamus DEVICE

All participants enrolled in this group 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.

Deep Brain Stimulation of the Motor Thalamus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
• Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
• 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.
• Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
• Participants must not be receiving anticoagulants.
• Severe claustrophobia.
• Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
• 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.
• 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).
• Medications with common cognitive side-effects.
• Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).
• Patients must not have any lesions in the lower motoneuron causing flaccid dysarthria.

Sponsors & Collaborators

• Jorge Gonzalez-Martinez: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (8)

• Ho, J. et al. TARGETED DEEP BRAIN STIMULATION OF THE MOTOR THALAMUS FACILITATES VOLUNTARY MOTOR CONTROL AFTER CORTICO-SPINAL LESIONS. medRxiv 2023-03 (2023).

  BACKGROUND

• Lozano AM, Lipsman N, Bergman H, Brown P, Chabardes S, Chang JW, Matthews K, McIntyre CC, Schlaepfer TE, Schulder M, Temel Y, Volkmann J, Krauss JK. Deep brain stimulation: current challenges and future directions. Nat Rev Neurol. 2019 Mar;15(3):148-160. doi: 10.1038/s41582-018-0128-2.

  PMID: 30683913 BACKGROUND

• Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y.

  PMID: 24353109 BACKGROUND

• Molnar GF, Sailer A, Gunraj CA, Cunic DI, Lang AE, Lozano AM, Moro E, Chen R. Changes in cortical excitability with thalamic deep brain stimulation. Neurology. 2005 Jun 14;64(11):1913-9. doi: 10.1212/01.WNL.0000163985.89444.DD.

  PMID: 15955943 BACKGROUND

• Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14.

  PMID: 37580534 BACKGROUND

• Cooper IS, Upton AR, Amin I. Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. Appl Neurophysiol. 1980;43(3-5):244-58. doi: 10.1159/000102263.

  PMID: 6975064 BACKGROUND

• Phillips NI, Bhakta BB. Affect of deep brain stimulation on limb paresis after stroke. Lancet. 2000 Jul 15;356(9225):222-3. doi: 10.1016/s0140-6736(00)02487-9.

  PMID: 10963204 BACKGROUND

• Franzini A, Cordella R, Nazzi V, Broggi G. Long-term chronic stimulation of internal capsule in poststroke pain and spasticity. Case report, long-term results and review of the literature. Stereotact Funct Neurosurg. 2008;86(3):179-83. doi: 10.1159/000120431. Epub 2008 Mar 12.

  PMID: 18334861 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Vascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jorge Gonzalez-Martinez, MD/PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cierra Clark, MS

CONTACT

240-441-4216; cic27@pitt.edu

Elvira Pirondini, PhD

CONTACT

412-636-0595; elvirap@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, non-randomized, open-label, descriptive, experimental.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 2 years from enrollment of the first participant.
• Access Criteria: Data must be directly requested from the PI and will be shared upon completion of the necessary data-sharing agreement to protect confidential patient information.

Locations

US (1)