New approach to control severe essential tremor using advanced brain stimulation
Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor
This study is testing a new brain stimulation device to see if it can better control severe tremors in people who haven't found relief with standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04212780 on ClinicalTrials.gov |
What this trial studies
This feasibility study explores the use of a dual lead thalamic deep brain stimulation (DBS) system to improve tremor control in patients with severe essential tremor who have not responded adequately to traditional DBS therapy. The study involves intraoperative experiments and chronic testing of the implanted device to assess its effectiveness in detecting tremor-related neurophysiological markers and providing targeted stimulation. If successful, the data gathered will inform future pivotal trials aimed at obtaining FDA approval for enhanced tremor control and adaptive DBS functionality.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with a diagnosis of essential tremor for at least three years who have not achieved satisfactory tremor control with existing DBS therapy.
Not a fit: Patients with non-essential tremor-related central nervous system diseases or those who do not meet the specific tremor severity criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve tremor control and quality of life for patients with severe essential tremor.
How similar studies have performed: While the concept of adaptive DBS is emerging, this specific dual lead approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Karim Oweiss, PhD — University of Florida
- Study coordinator: Cami Swartz
- Email: cami.swartz@neurology.ufl.edu
- Phone: 352-733-2429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.