Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2021
CompletedSeptember 17, 2021
September 1, 2021
1.8 years
March 8, 2019
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in tremor rating score
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.
One year
Study Arms (1)
Deep Brain Stimulation subjects
EXPERIMENTALInterventions
A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
Eligibility Criteria
You may qualify if:
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
- Age ≥ 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik H Middlebrooks
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 14, 2019
Study Start
March 20, 2019
Primary Completion
December 31, 2020
Study Completion
February 12, 2021
Last Updated
September 17, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share