Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Not Applicable
Completed
- Conditions
- Essential Tremor
- Interventions
- Diagnostic Test: Functional MRI
- Registration Number
- NCT03875404
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
- Age ≥ 18 years
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deep Brain Stimulation subjects Functional MRI -
- Primary Outcome Measures
Name Time Method Change in tremor rating score One year Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
1. = Slight.
2. = Moderate amplitude.
3. = Marked amplitude
4. = Severe amplitude
0 = Normal
1. = Mildly abnormal.
2. = Moderately abnormal.
3. = Marked abnormal.
4. = Severely abnormal.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States