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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875404
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Erik H. Middlebrooks, M.D., 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Diagnostic Test: Functional MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 20, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : February 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

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.




Primary Outcome Measures :
  1. Change in tremor rating score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875404


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Erik H Middlebrooks Mayo Clinic
Additional Information:
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Responsible Party: Erik H. Middlebrooks, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03875404    
Other Study ID Numbers: 18-010340
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Erik H. Middlebrooks, M.D., Mayo Clinic:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases