Essential TremorNCT02712515
The Motor Network in Essential Tremor: Mechanisms of Therapy
An observational study of Essential Tremor and Parkinson's Disease, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Essential Tremor, Parkinson's Disease
- What is being tested?
- Deep brain stimulation implantation surgery, Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips and FHC Guideline 4000+ system and/or Medtronic RC+S
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to 13 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurosurgical patient populations with essential tremor (main cohort) and Parkinson's disease (control cohort)
Who may be able to join
- Neurosurgical patient populations with essential tremor (main cohort) and Parkinson's disease (control cohort)
Who cannot join
- Non surgical candidates
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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 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 electromyogram (EMG) activity. Brain signals will be recorded using the clinical NeuroOmega system 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.
- Conditions
- Essential Tremor, Parkinson's Disease
- Being tested
- Deep brain stimulation implantation surgery, Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips, FHC Guideline 4000+ system and/or Medtronic RC+S
- Medical subject headings
- Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation implantation surgeryProcedure or 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 stripsDevice
Also called Ad-tech intraoperative monitoring 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+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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Deep brain stimulation implantation surgery; Device: Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips; Device: 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. Receives: Procedure: Deep brain stimulation implantation surgery; Device: Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips; Device: FHC Guideline 4000+ system and/or Medtronic RC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start15 Mar 2016
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysegul Gunduz, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712515
- Sponsor's protocol ID
- IRB201600172-N
- Other IDs
- 03UH3NS095553
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2016
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Motor Network in Essential Tremor: Mechanisms of Therapy
- ClinicalTrials.gov ID
- NCT02712515
- Acronym / sponsor ID
- IRB201600172-N
- Conditions
- Essential Tremor, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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 electromyogram (EMG) activity. Brain signals will be recorded using the clinical NeuroOmega system 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential tremor | – | Procedure: Deep brain stimulation implantation surgery, Device: Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips, Device: FHC Guideline 4000+ system and/or Medtronic RC+SParticipants 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 | – | Procedure: Deep brain stimulation implantation surgery, Device: Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips, Device: FHC Guideline 4000+ system and/or Medtronic RC+SParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgical patient populations with essential tremor (main cohort) and Parkinson's disease (control cohort)
Key inclusion criteria (1 listed)
- Neurosurgical patient populations with essential tremor (main cohort) and Parkinson's disease (control cohort)
Key exclusion criteria (1 listed)
- Non surgical candidates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation implantation surgeryDeep 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. | Procedure or surgery | Essential tremor, Parkinson's disease and dystonia |
| Ad-Tech Medical Instrumentation Corp. electrodes/subdural stripsAlso: Ad-tech intraoperative monitoring subdural stripsAd-Tech Medical Instrumentation Corp. electrodes are intraoperative monitoring subdural strips will be placed on the surface of the cortex (non-penetrating). | Device | Essential tremor, Parkinson's disease and dystonia |
| FHC Guideline 4000+ system and/or Medtronic RC+SBrain 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. | Device | Essential tremor, Parkinson's disease and dystonia |
Primary outcome
Brain signals between the groups
Time frame: intraoperative
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegul Gunduz, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Parkinson's Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain signals between the groups (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.