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Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor
Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor
Who can join
Ages 21 to 99 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- Medtronic Summit Rechargable (RC)+S (device)
- ipsilateral thalamic (VIM+VO) DBS (procedure)
- standard ET DBS (procedure)
- ipsilateral VO (procedure)
Sponsor: University of Florida · Participants: 10 · Started: Dec 24, 2019
Contact the study team
- Cami Swartz · Phone: 352-733-2429
- Karim Oweiss, PhD · Phone: 352-294-1898
Official record on ClinicalTrials.gov — NCT04212780
Locations in the U.S.
| Florida | University of Florida, Gainesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.