Recruiting

DBR-DBS Interface

Sponsor:

University of Florida

Code:

NCT04212780

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Medtronic Summit Rechargable (RC)+S

ipsilateral thalamic (VIM+VO) DBS

standard ET DBS

ipsilateral VO

Study Details

Brief 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.

Conditions

Essential Tremor

Study ID

NCT04212780

Start date

Dec 24, 2019

Status verified date

Aug, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 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 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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Treatment Naive

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

active comparator: Refractory Participants

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

Interventions

Medtronic Summit Rechargable (RC)+S

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

ipsilateral thalamic (VIM+VO) DBS

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

standard ET DBS

Single Lead VIM

ipsilateral VO

second lead in the ipsilateral VO

Primary outcome measure

  • Efficacy Assessment - Tremor [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Cami Swartz

352-733-2429cami.swartz@neurology.ufl.edu

Karim Oweiss, PhD

352-294-1898koweiss@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

More Information

Sponsor

University of Florida

Last update posted

Feb 10, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.