Recruiting

Deep Brain Stimulation

Sponsor:

Jorge Gonzalez-Martinez

Code:

NCT07056361

Conditions

Movement Disorders (Incl Parkinsonism)

Stroke

Traumatic Brain Injury

Brain Diseases

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Direct cortical stimulation and deep brain stimulation of motor thalamus

Study Details

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

Study ID

NCT07056361

Start date

Dec 16, 2022

Status verified date

Oct, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Direct cortical stimulation and deep brain stimulation of motor thalamus

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.

Primary outcome measure

  • Electromyography Activity [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Cierra Clark, MS

240-441-4216cic27@pitt.edu

Elvira Pirondini, PhD

412-636-0595elvirap@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Cierra Clark, MS

240-441-4216cic27@pitt.edu

Elvira Pirondini, PhD

412-636-0595elvirap@pitt.edu

Principal Investigator:

Jorge Gonzalez-Martinez, MD, PhD

More Information

Sponsor

Jorge Gonzalez-Martinez

Last update posted

Nov 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jorge Gonzalez-Martinez on 2025-11-10.