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RecruitingNCT04212780Updated Feb 10, 2026

Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor

An interventional study of Medtronic Summit Rechargable (RC)+S and ipsilateral thalamic (VIM+VO) DBS in Essential Tremor, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by University of Florida · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
21 Years to 99 Years
Sex
All
01

Study summary

This is a feasibility study based on physician-initiated Investigational Device Exemption (IDE) including intraoperative experiments and chronic testing of implanted dual thalamic DBS lead systems. This study will inform protocols for optimal use of implanted next-gen DBS systems for primarily tremor control in refractory essential tremor.If the approach appears to be successful, the pilot data generated will be used to base a future pivotal trial for FDA approval for enhanced tremor control and adaptive DBS (aDBS) functionality of DBS systems.

Read the detailed description

Ventralis intermedius nucleus of the thalamus (VIM) Deep Brain Stimulation (DBS) has emerged as a highly effective treatment for essential tremor, which is an incurable, degenerative brain disorder that results in progressively debilitating tremor, afflicting an estimated 7 million people in the US (2.2% of the population). Clinical observation shows, however, that disease progression results in eventual recurrence of debilitating tremor in 10 to 20% of VIM DBS patients. DBS revision surgery, with replacement of sub-optimally positioned VIM DBS leads and addition of an ipsilateral ventralis oralis (VO) DBS lead, has emerged as an effective rescue strategy for many such patients with delayed failure of VIM DBS therapy.

Since essential tremors are typically not continuous, tremor suppressing DBS therapy need not necessarily be delivered continuously and could theoretically be effective if delivered only when movement intent or tremor is present.

Our central hypothesis is that a VIM+VO DBS system capable of detecting the neurophysiologic markers of essential tremor (ET) associated with goal directed movements, and providing responsive dual lead thalamic stimulation in a targeted and personalized manner, would provide improved suppression of severe tremor, reduce adverse effects associated with continuous stimulation, and prolong the battery life of the implantable neurostimulator (INS), decreasing the frequency of surgical procedures necessary to replace devices with depleted batteries.

02

Conditions studied

  • Essential Tremor

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03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 10 is below the median of 25 across 189 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Browse University of Florida studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient gives an .
  • Patient is over 21 years of age.
  • Patient is diagnosed with a postural-intention (essential) tremor for at least 3 years, meets diagnostic criteria for ET, has been evaluated and examined by a movement disorders fellowship trained neurologist, and is being treated with traditional VIM DBS therapy.
  • Patient has no evidence of non-ET central nervous system disease or injury and has had a significantly disabling, upper extremity tremor despite ongoing VIM DBS therapy for at least three (3) months prior to DBS revision surgery.
  • Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (TRS) despite ongoing VIM DBS therapy.
  • Patient has a TRS score of 2 or above in any one of the items 16-23 from the Disability subsection of the TRS: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working and social activities despite ongoing VIM DBS therapy.
  • Patient's tremor is to adequate trials of at least two medications, one of which should be either propranolol or primidone. Proof of this is not required for patients with a current device that is being removed and replaced with a new device. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
  • Patient is available for appropriate follow-up times for the length of the study.

Exclusion criteria

Exclusion Criteria:

  • Any previous neurosurgical intervention other than VIM DBS, including ablative brain lesions for tremor suppression.
  • Medication related movement disorders.
  • Any suspicion of Parkinson's disease, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.
  • Any behaviors consistent with alcohol or substance abuse as defined by the criteria outlined in (DSM-V).
  • Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
  • Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions. Also excluded will be subjects with severe brain atrophy.
  • Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
  • A history of seizures within the past year.
  • A dementia rating scale score (DRS) \<130 signifying significant cognitive dysfunction and a potential for inability to cooperate with tasks involved in the study.
  • Any attempt or intent of suicide during the previous six months.
  • Presence or history of psychosis.
  • Any person known to have abnormal coagulation or any medications which interfere with coagulation
  • Significant untreated or unstable mood disorders including depression. This will be determined by the Neuropsychological team during FastTrack and by the Neurologist
  • In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    Treatment Naive

    Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor

    Device: Medtronic Summit Rechargable (RC)+S · Procedure: standard ET DBS · Procedure: ipsilateral VO

  • Active comparator
    Refractory Participants

    Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy

    Device: Medtronic Summit Rechargable (RC)+S · Procedure: ipsilateral thalamic (VIM+VO) DBS

Interventions

  • DeviceMedtronic Summit Rechargable (RC)+S

    Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO

  • Procedureipsilateral thalamic (VIM+VO) DBS

    Implantation of two new ipsilateral thalamic (VIM+VO) DBS

  • Procedurestandard ET DBS

    Single Lead VIM

  • Procedureipsilateral VO

    second lead in the ipsilateral VO

06

What researchers measure

Primary outcomes

  1. Efficacy Assessment - Tremor

    Tremor rating scale This 5-point scale rates tremor severity based on tremor amplitude, from 0 (no tremor) to 4 (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Dec 2027, 96 months after the start.

Of 77 non-industry interventional studies with no phase under Essential Tremor, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 26. This study's planned 96 months is above that.

Counting every sponsor, half of 95 studies reached it within 45 months; a quarter within 19 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2019
First posted
Dec 30, 2019
StartActual
Dec 24, 2019
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2029
Last update
Feb 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04212780
Lead sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
Responsible party
Sponsor
First posted
Dec 30, 2019
Start date
Dec 24, 2019
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 10, 2026

Study contacts

Cami Swartz
Contact
cami.swartz@neurology.ufl.edu
352-733-2429
Karim Oweiss, PhD
Contact
koweiss@ufl.edu
352-294-1898
Karim Oweiss, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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