Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303869
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-03-04
Brief Title:
Deep Brain Stimulation Motor Ventral Thalamus VOPVIM for Restoration of Speech and Upper-limb Function in People with Subcortical Stroke
Sponsor:
Jorge Gonzalez-Martinez
Organization:
University of Pittsburgh
Study Overview
Official Title:
Deep Brain Stimulation Motor Ventral Thalamus VOPVIM for Restoration of Speech and Upper-limb Function in People with Subcortical Stroke
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study is designed to assess the assistive effects of DBS ie immediate effects when the stimulation is turned ON and obtain preliminary evidence for therapeutic effects ie long-lasting effects with stimulation OFF Researchers will 1 quantify the ability to recruit face muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke 2 quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke and 3 verify if the delivery of DBS has effects on the central nervous system with clinical measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None