Study Summary
This trial is testing a new, improved deep brain stimulator that only gives off pulses when the patient is actually experiencing tremors. The goal is to reduce side effects and improve quality of life for people with essential tremor.
Eligible Conditions
- Essential Tremor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 24 months post-surgery
24 months post-surgery
Clinical Rating Scale for Tremor (CRST) for continuous deep brain stimulation
Month 24
Clinical Rating Scale for Tremor (CRST) for closed-loop deep brain stimulation
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Deep brain stimulation
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Deep brain stimulation · No Placebo Group · N/A
Deep brain stimulationExperimental Group · 2 Interventions: Closed-loop deep brain stimulation, Deep brain stimulation · Intervention Types: Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~330
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months post-surgery
Who is running the clinical trial?
MedtronicIndustry Sponsor
574 Previous Clinical Trials
732,871 Total Patients Enrolled
5 Trials studying Essential Tremor
147 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,260 Previous Clinical Trials
454,505 Total Patients Enrolled
20 Trials studying Essential Tremor
7,522 Patients Enrolled for Essential Tremor
University of FloridaLead Sponsor
1,248 Previous Clinical Trials
698,655 Total Patients Enrolled
9 Trials studying Essential Tremor
439 Patients Enrolled for Essential Tremor
Aysegul Gunduz, Ph.DPrincipal InvestigatorUniversity of Florida
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have had a disabling tremor in your upper extremity that has not been controlled by medications for at least three months before implant.
You have had a 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 (CRST).
If you have scored 2 or above in any one of the items 16-23 from the Disability subsection of the CRST, this indicates you have a disability.
Based on the results of your tests, it seems that your tremors are not responding to treatment with propranolol or primidone
If you are available for follow-up appointments for the study's duration, please let us know what times work best for you.
I consent to you providing me with information.
You are of legal drinking age.
You have been diagnosed with a postural-intention tremor that has been present for at least 3 years and meets strict diagnostic criteria
Who else is applying?
What state do they live in?
| Florida | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments