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New treatment option for Essential Tremor
Official title Coordinated Reset Deep Brain Stimulation for Essential Tremor
ClinicalTrials.gov ID: NCT05897775
What this study is testing
- What it's testing
- Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Diagnosis of essential tremor (ET)
- Age of 21 or over
- Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging...
- Planned post-operative CT scan
You likely can't join if
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Other significant neurological disorder
- History of dementia or cognitive impairment that precludes them from getting DBS surgery
- Significant psychiatric disease
- On medication that could cause tremor
- Prior brain surgery
See the full eligibility criteria
- Diagnosis of essential tremor (ET)
- Age of 21 or over
- Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI"
- Planned post-operative CT scan
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Other significant neurological disorder
- History of dementia or cognitive impairment that precludes them from getting DBS surgery
- Significant psychiatric disease
- On medication that could cause tremor
- Prior brain surgery
- Pregnant women
- Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- Other significant medical disorder that could impede study participation
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.