Back to resultsNext-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional MRI
Sponsored by
About this trial
This is an interventional basic science trial for Essential Tremor focused on measuring Deep Brain Stimulation
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation subjects
Arm Description
Outcomes
Primary Outcome Measures
Change in tremor rating score
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
= Slight.
= Moderate amplitude.
= Marked amplitude
= Severe amplitude
0 = Normal
= Mildly abnormal.
= Moderately abnormal.
= Marked abnormal.
= Severely abnormal.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03875404
Brief Title
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Official Title
Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation subjects
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in tremor rating score
Description
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
= Slight.
= Moderate amplitude.
= Marked amplitude
= Severe amplitude
0 = Normal
= Mildly abnormal.
= Moderately abnormal.
= Marked abnormal.
= Severely abnormal.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik H Middlebrooks
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
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