Stimulating Specific Brain Areas (VOP/VIM) With Electricity to Improve Movement and Muscle Control

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jorge Gonzalez-Martinez
Study ID
NCT07056361
Status
Recruiting
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Conditions

  • Brain Diseases
  • Essential Tremor, Movement Disorders
  • Movement Disorders (Incl Parkinsonism)
  • Parkinson Disease
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Direct cortical stimulation and deep brain stimulation of motor thalamus — DEVICE
    All participants enrolled will undergo implantation of deep brain stimulation electrode leads for treatment of movement disorders. In addition to standard-of-care subcortical mapping using micro-electrode recording (MER) and macrostimulation 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. The strip electrode over M1 will be used to produce motor evoked potentials to contralateral hand muscles from direct cortical stimulation (DCMEPs). Cortical and subcortical LFPs will be obtained alongside electromyographic (EMG) data while the patient performs contralateral upper extremity movement tasks and a variety of articulation exercises.

Study Details

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.

Key Dates

Start date
Dec 16, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Direct Cortical Stimulation and Deep Brain Stimulation of the Motor Thalamus
    Individuals undergoing deep brain stimulation device implanted in the motor thalamus for movement disorders treatment. Some of whom may also sustain speech, swallowing, and motor deficits.

Primary Outcome Measure

Electromyography Activity [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Cierra Clark, MS
[email protected]
240-441-4216
Elvira Pirondini, PhD
[email protected]
412-636-0595
Jorge Gonzalez-Martinez, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Parkinson's diseaseStroke
By specialty
NeurologyBrain disorders
By research site
University of Pittsburgh· Pittsburgh, PA

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