Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor
University of Florida
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.
Description
Ventralis intermedius nucleus of the thalamus (VIM) Deep Brain Stimulation (DBS) has emerged as a highly effective treatment for essential tremor, which is an incurable, degenerative brain disorder that results in progressively debilitating tremor, afflicting an estimated 7 million people in the US (2.2% of the population). Clinical observation shows, however, that disease progression results in eventual recurrence of debilitating tremor in 10 to 20% of VIM DBS patients. DBS revision surgery, with replacement of sub-optimally positioned VIM DBS leads and addition of an ipsilateral ventralis or…
Eligibility
- Age range
- 21–99 years
- Sex
- All
- Healthy volunteers
- Yes
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. * Patien…
Interventions
- DeviceMedtronic Summit Rechargable (RC)+S
Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO
- Procedureipsilateral thalamic (VIM+VO) DBS
Implantation of two new ipsilateral thalamic (VIM+VO) DBS
- Procedurestandard ET DBS
Single Lead VIM
- Procedureipsilateral VO
second lead in the ipsilateral VO
Location
- University of FloridaGainesville, Florida