Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Not Applicable

Completed

• Conditions: Essential Tremor

• 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

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-03-20
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-17

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

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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States