NCT02712515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

January 13, 2026

Status Verified

August 1, 2025

Enrollment Period

9.6 years

First QC Date

March 15, 2016

Last Update Submit

January 12, 2026

Conditions

Essential TremorParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Brain signals between the groups

    FHC Guideline 4000+ system or Medtronic devices will be connected to Ad-Tech Medical Instrumentation Corp. electrodes and deep brain electrodes to measure brain signals between the groups

    intraoperative

Study Arms (2)

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.

Procedure: Deep brain stimulation implantation surgeryDevice: Ad-Tech Medical Instrumentation Corp. electrodes/subdural stripsDevice: FHC Guideline 4000+ system and/or Medtronic RC+S

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.

Procedure: Deep brain stimulation implantation surgeryDevice: Ad-Tech Medical Instrumentation Corp. electrodes/subdural stripsDevice: FHC Guideline 4000+ system and/or Medtronic RC+S

Interventions

Deep brain stimulation implantation surgeryPROCEDURE

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.

Essential tremorParkinson's disease and dystonia
Ad-Tech Medical Instrumentation Corp. electrodes/subdural stripsDEVICE

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

Also known as: Ad-tech intraoperative monitoring subdural strips
Essential tremorParkinson's disease and dystonia
FHC Guideline 4000+ system and/or Medtronic RC+SDEVICE

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.

Essential tremorParkinson's disease and dystonia

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Non surgical candidates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Essential TremorParkinson Disease

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aysegul Gunduz, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

March 15, 2016

Primary Completion

October 13, 2025

Study Completion

October 13, 2025

Last Updated

January 13, 2026

Record last verified: 2025-08

Locations

US(1)