Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
100

Summary

Conditions
  • Essential Tremor
  • Parkinson's Disease
Type
Observational
Design
Observational Model: CohortTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Description

The research study goal is to advance the understanding of the mechanisms for essential tremor through brain recordings. The investigators will collect brain signals in persons with essential tremor undergoing neurosurgical treatment (deep brain stimulation implantation). By recording from the impla...

The research study goal is to advance the understanding of the mechanisms for essential tremor through brain recordings. The investigators will collect brain signals in persons with essential tremor undergoing neurosurgical treatment (deep brain stimulation implantation). By recording from the implanted electrodes for deep brain stimulation along with two other non-invasive intraoperative monitoring electrodes, the origins of tremor will be studied in the human motor network. Moreover, by performing recordings during deep brain stimulation delivery, the mechanisms in which deep brain stimulation modulates this network to suppress tremor will be investigated. During the standard of care DBS procedure neural recordings are performed as the participant is in a reclined position on the operating table. In addition to neural recordings it is standard to ask the patient to move their arms and legs during the procedure. An additional intraoperative monitoring subdural electrode strip, used in epilepsy and tumor surgeries to perform functional mapping, will be placed by the neurosurgeon after the DBS electrode is placed per the clinical need of the patient. 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 or Medtronic RC+S, which are devices capable of recording during stimulation. This additional testing will add approximately 30-45 minutes to the surgical time. The Medtronic RC+S stimulator will not be implanted in these subjects, and will not used as a therapy. No interventions are compared against any controls for this study.

Tracking Information

NCT #
NCT02712515
Collaborators
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Medtronic
Investigators
Principal Investigator: Aysegul Gunduz, PhD University of Florida