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

NCT04212780 | Recruiting DMC FDA Device

• 4 other identifiers: IRB201901021OCR296221UH3NS109845-015UH3NS109845-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Up to 24 months

Study Arms (2)

Treatment Naive

ACTIVE COMPARATOR

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

Refractory Participants

ACTIVE COMPARATOR

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

Medtronic Summit Rechargable (RC)+S DEVICE

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

Refractory Participants; Treatment Naive

ipsilateral thalamic (VIM+VO) DBS PROCEDURE

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

Refractory Participants

standard ET DBS PROCEDURE

Single Lead VIM

Treatment Naive

ipsilateral VO PROCEDURE

second lead in the ipsilateral VO

Treatment Naive

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medtronic: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Karim Oweiss, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cami Swartz

CONTACT

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

Karim Oweiss, PhD

CONTACT

352-294-1898; koweiss@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 30, 2019
• Study Start: December 24, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)