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

NCT ID: NCT03875404

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-02-12

Brief Summary

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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

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Conditions

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Essential Tremor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation subjects

Group Type EXPERIMENTAL

Functional MRI

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Erik H. Middlebrooks, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik H Middlebrooks

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-010340

Identifier Type: -

Identifier Source: org_study_id

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