Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT07056361
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulating Specific Brain Areas (VOP/VIM) With Electricity to Improve Movement and Muscle Control
Sponsor:
Jorge Gonzalez-Martinez
Organization:
Study Overview
Official Title:
VOP/VIM Direct Electrical Stimulation Increases Motor Cortex Excitability and Motor Output
Status:
RECRUITING
Status Verified Date:
2025-10
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:
In this study the investigators aim to enroll patients scheduled to undergo deep brain stimulation (DBS) implantation for movement disorders for intra-operative testing. In addition to standard-of-care surgical procedure to implant deep brain stimulation electrode leads, participants will also be stimulated and recorded from cortical areas by a temporary strip electrode (1X6) in the subdural space. The electrodes will be connected to external stimulators and a series of experiments will be performed to assess effects of the DBS on movement quality and electrophysiology measures. Results of this study will elucidate the biological mechanisms related to deep brain stimulation in modulating motor and speech function in patients with abnormal movement disorders.
Detailed Description:
In this study the investigators aim to enroll patients for intra-operative testing. Specifically, the investigators will recruit patients already undergoing DBS implantation for movement disorders. In addition to standard-of-care subcortical mapping using micro-electrode recording (MER) and macro-stimulation mapping during DBS placement, cortical local field potentials (LFPs) will be simultaneously recorded from primary motor (M1) and somatosensory (S1) cortical areas by placement of a temporary strip electrode (1X6) in the subdural space. Appropriate localization of this grid over M1 and S1 will be confirmed by the so-called phase-reversal of somatosensory evoked potentials (SSEPs). Once M1 is localized, the strip electrode over M1 will be used to produce motor evoked potentials to contralateral hand muscles from direct cortical stimulation (DCMEPs). The stimulation threshold of the DCMEPs will be used as a direct measure of the excitability of the cortical spinal tract and compared with and without stimulation of the VOP/VIM nuclei. Cortical and subcortical LFPs will be obtained alongside electromyographic (EMG) data while the patient performs contralateral upper extremity movement tasks measuring velocity, grip strength, and strength modulation and while the patient perform a variety of articulation exercises. Along with the DCMEP stimulation thresholds, these parameters of motor output will be obtained both with and without VOP/VIM stimulation to assess for stimulation induced potentiation of motor output.
Study Oversight
Has Oversight DMC:
False
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?: