A Study Evaluating the Use of Thalamic Deep Brain Stimulation (DBS) in the Treatment of Tremor
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-010340
NCT ID: NCT03875404
Sponsor Protocol Number: 18-010340
About this study
The purpose of this study is to directly compare the predictability of tremor reduction between two thalamic Deep Brain Stimulation (DBS) strategies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement.
- Age ≥ 18 years old.
Exclusion Criteria:
- Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor.
- Presence of concomitant movement disorder (e.g. Parkinson’s disease, dystonia, etc.).
- Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.).
- Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device).
- Pregnant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Erik Middlebrooks, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available