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

NCT07056361 | Recruiting FDA Device

• 1 other identifier: STUDY22100174
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Electromyography Activity

  The investigators will record electromyography activity (EMG) to measure the motor evoked potentials of upper limb and facial muscles. At the end of the procedures these needles and/or the superficial adhesive electrodes will be removed. Based on the preliminary data, the investigators will consider the number of participants with at least an 18% increase in muscle activation as minimally acceptable.

  14 days

Secondary Outcomes (5)

• Facial Muscle Motor Function - Muscle Strength

  14 days

• Facial Muscle Motor Function - Range of Motion

  14 days

• Speech Intelligibility

  14 days

• Dexterity of Articulation AMRs

  14 days

• Dexterity of Articulation SMRs

  14 days

Study Arms (1)

Direct Cortical Stimulation and Deep Brain Stimulation of the Motor Thalamus

EXPERIMENTAL

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.

Device: Direct cortical stimulation and deep brain stimulation of motor thalamus

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.

Direct Cortical Stimulation and 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:

• Essential tremor patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with asymmetric essential tremor symptoms will be included, with the tested limb corresponding to the least affected arm to better approximate normal function. These patients are implanted bilaterally regardless of symptom laterality, as the natural history of essential tremor indicates eventual bilateral symptoms.
• Parkinson's Disease patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with a history of Parkinson's Disease will also be recruited for intra-operative stimulation of their STN-targeted implants, to assess if VIM/VOP has high specificity for improving motor output.
• Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.

You may not qualify if:

• Patients will be excluded from the study if there is any seizure history, to avoid the increased epileptogenic risk of intraoperative stimulation.
• Patients with significant bilateral tremor that precludes completion of motor tasks.

Sponsors & Collaborators

• Jorge Gonzalez-Martinez: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Movement Disorders; Stroke; Brain Injuries, Traumatic; Brain Diseases; Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases

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: June 25, 2025
• First Posted: July 9, 2025
• Study Start: December 16, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-10

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 7 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)