Study Details
Testing the Abbott Deep Brain Stimulation Outcomes Over Time
(IRB#: IRB_00128661)
This study is testing an approved device called the Abbott Deep Brain Stimulation (DBS) system. The device is an implant that helps treat a persons movement disorder. The study is testing to see the long-term safety and effectiveness of the device. The participant's doctor will need to recommend the treatment. People in the study will attend in-person visits that are part of the standard of care with the Neurologist. Participants will complete surveys to collect information about the safety and effectiveness of the treatment over time. Being in the study lasts 5 years.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Diagnosed with Parkinsons disease, essential tremor, or another disabling tremor
- Scheduled for a new implant or implantable pulse generator device replacement surgery with a market-released Abbott DBS system within 180 days
Exclusion Criteria
- Currently enrolled or plans to enroll in a study that may impact the results of this study
- DBS implant is NOT an essential tremor
- Intended lead implant location is NOT at, or near, the Ventral Intermediate Nucleus (VIM) thalamus (the effective target of the DBS)
- Intended lead implant is NOT a replacement implantable pulse generator for leads in the VIM
- Other medical condition that limits the ability to participate
Will I be paid for my time?
Yes
IRB#: IRB_00128661
PI: Paolo Moretti
Department: NEUROLOGY
Approval Date: 2020-07-31 19:21:00
Study Categories: Brain Health Studies
Specialties: Neurology, Neurosurgery