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

A vizsgálat adatai

Ki végzi

University of Florida

Azonosító

NCT04212780

A regiszteradat frissítve

2026. február 10.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor

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.

Bevonási feltételek: 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.

Kizáró feltételek: Any previous neurosurgical intervention other than VIM DBS, including ablative brain lesions for tremor suppression; Any attempt or intent of suicide during the previous six months; Any person known to have abnormal coagulation or any medications which interfere with coagulation; 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; 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; Presence or history of psychosis; Significant untreated or unstable mood disorders including depression. This will be determined by the Neuropsychological team during FastTrack and by the Neurologist; Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema); In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.

ClinicalTrials.gov NCT04212780