This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Deep Brain Stimulation

Sponsor:

University of Florida

Code:

NCT02712515

Conditions

Essential Tremor

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation implantation surgery

Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips

FHC Guideline 4000+ system and/or Medtronic RC+S

Study Details

Brief summary:

Essential tremor (ET) is among the most common movement disorders, and is the most prevalent tremor disorder. It is a progressive, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2% of the population) and estimates from population studies worldwide range from 0.4% to 6.3%. ET is directly linked to progressive functional impairment, social embarrassment, and even depression. Intention (kinetic) tremor of the arms occurs in approximately half of ET patients, and is typically a slow tremor (\~5-10Hz) that occurs at the end of a purposeful movement, and is insidiously progressive over many years. Based on direct and indirect neurophysiological studies, it has been suggested that a pathological synchronous oscillation in a neuronal network involving the ventral intermediate nucleus (Vim) of the thalamus, the premotor (PM), primary motor (M1) cortices, and the cerebellum, may result in the production of ET. In spite of the numerous therapeutic modalities available, 65% of those suffering from upper limb tremor report serious difficulties during their daily lives. Deep brain stimulation (DBS) has emerged as an effective treatment option for those suffering from medically refractory ET. The accepted target for ET DBS therapy is the Vim thalamus. Vim projects to PM, M1, and supplementary motor areas (SMA) and receives afferents from the ipsilateral cerebellum. Moreover, electrophysiological recordings from Vim during stereotactic surgery have identified "tremor cells" that synchronously discharge with oscillatory muscle activity during tremor. Clinical and computational findings indicate that DBS suppresses tremor by masking these "burst driver" inputs to the thalamus. The overall goal is to investigate the neural signatures of tremor generation in the thalamocortical network by recording data during DBS implantation surgery. Investigators will record data from the macroelectrode implanted in the Vim for DBS therapy, and through an additional 6-contact subdural cortical strip that will be placed on the hand motor cortical area temporarily through the same burr hole opened for the implantation of the DBS electrode.

Conditions

Essential Tremor

Parkinson's Disease

Study ID

NCT02712515

Start date

Mar, 2016

Status verified date

Aug, 2025

Completion date

Nov 3, 2028

Anticipated

Primary completion date

Nov 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Neurosurgical patient populations with essential tremor (main cohort) and Parkinson's disease (control cohort)

Exclusion Criteria:

  • Non surgical candidates

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Essential tremor

Participants in this group will be undergoing deep brain stimulation implantation surgery as part of the standard of care. In addition, the Ad-Tech Medical Instrumentation Corp. device will be used to test responses with wireless sensors placed on the participant's arms, which can record EMG activity. Brain signals will be recorded using the clinical FHC Guideline 4000+ system and/or Medtronic RC+S devices, which are capable of recording during stimulation.

Parkinson's disease and dystonia

Participants in this group with Parkinson's disease and/or dystonia will be undergoing deep brain stimulation implantation surgery as part of the standard of care. In addition, the Ad-Tech Medical Instrumentation Corp. device will be used to test responses with wireless sensors placed on the participant's arms, which can record EMG activity. Brain signals will be recorded using the clinical FHC Guideline 4000+ system and/or Medtronic RC+S devices, which are capable of recording during stimulation.

Interventions

Deep brain stimulation implantation surgery

Deep brain stimulation is a neuromodulatory therapy in which electrodes are implanted in deep brain structures. Electrical pulses are delivered through these electrodes to suppress pathological activity that are causing the symptoms of essential tremor or Parkinson's disease.

Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips

Ad-Tech Medical Instrumentation Corp. electrodes are intraoperative monitoring subdural strips will be placed on the surface of the cortex (non-penetrating).

FHC Guideline 4000+ system and/or Medtronic RC+S

Brain signals will be recorded using the clinical Participants in this group with Parkinson's disease will be undergoing deep brain stimulation implantation surgery as part of the standard of care. In addition, the Ad-Tech Medical Instrumentation Corp. device will be used to test responses with wireless sensors placed on the participant's arms, which can record EMG activity. Brain signals will be recorded using the clinical FHC Guideline 4000+ system and/or Medtronic RC+S devices, which are capable of recording during stimulation.

Primary outcome measure

  • Brain signals between the groups [ Time Frame: intraoperative ]

Central Contacts and Locations

Central contacts

Aysegul Gunduz, PhD

3522736877agunduz@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

More Information

Sponsor

University of Florida

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by University of Florida on 2025-08-14.