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

ConditionEssential Tremor

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-99

SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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
ipsilateral thalamic (VIM+VO) DBS
Procedure/Surgery
Implantation of two new ipsilateral thalamic (VIM+VO) DBS
standard ET DBS
Procedure/Surgery
Single Lead VIM
ipsilateral VO
Procedure/Surgery
second lead in the ipsilateral VO

Treatment groups

10 Participants

are divided into 2 treatment groups

Group A: Treatment NaiveActive comparator 3 interventions

Group B: Refractory ParticipantsActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov

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