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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03875404
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
22.8
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Functional MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Feb 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deep Brain Stimulation subjects

Diagnostic Test: Functional MRI
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.

Outcome Measures

Primary Outcome Measures

  1. Change in tremor rating score [One year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Florida Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Erik H Middlebrooks, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Erik H. Middlebrooks, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03875404
Other Study ID Numbers:
  • 18-010340
First Posted:
Mar 14, 2019
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erik H. Middlebrooks, M.D., Principal Investigator, Mayo Clinic
Deep Brain Stimulation
Additional relevant MeSH terms:
Tremor
Essential Tremor

Study Results

No Results Posted as of Sep 17, 2021