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Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Essential Tremor

This study is looking at a new way to treat severe essential tremor, a condition that causes uncontrollable shaking. It's testing a device called Medtronic Summit Rechargable (RC)+S, which is a special pulse generator connected to two deep brain stimulation (DBS) leads implanted in your brain (VIM and VO areas of the thalamus). This device aims to detect tremor and deliver stimulation only when needed, potentially improving tremor control, reducing side effects, and extending battery life compared to standard DBS. You might be able to join if you are between 21 and 99 years old, have had essential tremor for at least three years, and are currently being treated with traditional VIM DBS. The main goal is to see how well this new approach reduces tremor over up to 24 months. The current recruitment status is unclear.

Study design
This is a feasibility study involving 10 participants to test a new deep brain stimulation system. It's an interventional study, meaning participants will receive a specific treatment.
What's involved
You would undergo implantation of two new ipsilateral thalamic (VIM+VO) DBS leads. The study will involve intraoperative experiments and chronic testing of the implanted system.
Compensation
Not stated in the trial record.
Follow-up
Your tremor will be assessed for efficacy for up to 24 months after the intervention.

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NCT04212780

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

Recruiting
NAAges 21–99InterventionalDevice feasibility
University of Florida
~10 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Medtronic Summit Rechargable (RC)+Sipsilateral thalamic (VIM+VO) DBSstandard ET DBSipsilateral VO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy Assessment - Tremor
Measured over Up to 24 months

Conditions

Essential Tremor

Explore related trials

Essential Tremor

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Karim Oweiss, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Cami Swartz
[email protected]
352-733-2429
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient gives an informed consent.
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 refractory 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

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 Diagnostic and Statistical Manual of Mental Disorders (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.

What this trial measures

  • Efficacy Assessment - TremorUp to 24 months

    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.