RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06303869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing). 3. Native English speaker. 4. Patients with moderate to severe dysarthria (50-89% intelligibility in the Assessment of Intelligibility of Dysarthric Speech test).	1. Patients who refuse participation in the study. 2. Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas. 3. Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy. 4. Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments. 5. 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. 6. Female participants of child-bearing age must not be pregnant, planning to become pregnant 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 the duration of the study. 10. 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 11. Evaluation to sign consent form score \<12. 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). 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 flaccid dysarthria.

Inclusion Criteria

Exclusion 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 outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing).
3. Native English speaker.
4. Patients with moderate to severe dysarthria (50-89% intelligibility in the Assessment of Intelligibility of Dysarthric Speech test).

1. Patients who refuse participation in the study.
2. Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
3. Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
4. Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
5. 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.
6. Female participants of child-bearing age must not be pregnant, planning to become pregnant 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 the duration of the study.
10. 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
11. Evaluation to sign consent form score \<12.
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).
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 flaccid dysarthria.

Contacts and Locations

Study Contact

Cierra Clark, MS

CONTACT

240-441-4216

cic27@pitt.edu

Elvira Pirondini, PhD

CONTACT

412-636-0595

elvirap@pitt.edu

Principal Investigator

Jorge Gonzalez-Martinez, MD/PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Jorge Gonzalez-Martinez

Jorge Gonzalez-Martinez, MD/PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2029-12

Study Record Updates

Study Start Date2024-11

Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

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