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Electromagnetic Tracking to Measure Tremor

NCT ID: NCT02641366

Last Updated: 2017-10-26

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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Deep Brain Stimulation (DBS) is an effective treatment option for individuals with debilitating tremors that do not respond to medical therapy. However, severe tremors, particularly those that develop after central nervous system insult or from multiple sclerosis, can be comprised of several underlying components that represent dysfunction within distinct brain circuits. Some of these dysfunctional brain circuits can be successfully treated with DBS while others respond poorly DBS therapy. For severe tremors, it can be very difficult to discriminate between the underlying components of a patient movement disorder and is exclusively dependent upon clinical expertise. Even with extensive clinical experience, it is difficult to reliably predict the results of DBS therapy for patients suffering from severe, debilitating tremor. In an attempt to gain more knowledge, an electromagnetic tracking system will be used which can precisely measure the position of a patient's upper extremity in space during routine neurologic examination. The goal is to use this tool to quantitatively identify various components of severe tremor, which can be discriminated based on oscillatory frequency and regularity of tremor amplitude. The purpose of this research study is to better understand the nature of complex, severe tremors by carefully measuring movement of the upper extremities with sensors during simple tasks. The goal is to break down complicated tremors into their components and then determine which components will respond to deep brain stimulation.

Detailed Description

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As a participant in the research study small sensors that are connected to wires will be affixed to points on your hand, wrist, elbow and/or shoulder. These sensors are painless and otherwise noninvasive. They will be used to measure the precise location of the hand and arm in space during the neurologic examination. This exam will test the tremors during short, simple tasks using the hand and arm. This information will be stored along with your name and medical record number for analysis after your testing is complete.

The sensors that are used to measure movements are connected to thin, flexible wires that will be attached with adhesive tape. The motion sensors use a magnet that produces a weak electromagnetic field. This electromagnetic field poses no direct harm, but could potentially interfere with medical devices such as cardiac pacemakers or deep brain stimulators if placed very close to the electromagnetic emitter.

Conditions

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Tremor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tremor kinetics after DBS

This group have already undergone Deep Brain Stimulation (DBS) placement and will have measurements of tremor kinetics by using the electromagnetic tracking. The electromagnetic sensors will be placed on the arm and hand while the routine outpatient neurologic examinations are being performed. The testing will be performed with the DBS system in both the on and off settings.

Electromagnetic tracking

Intervention Type DEVICE

The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.

Tremor kinetics after DBS

Intervention Type PROCEDURE

We will fit the patient with the electromagnetic sensors and then perform routine outpatient neurologic examinations with their DBS system in both the DBS on and the DBS off settings.

Tremor kinetics before and after DBS

This group will have measurements of tremor kinetics by using electromagnetic tracking prior to being scheduled to undergo Deep Brain Stimulation (DBS) placement. A total of two testing sessions will be performed: the first session will be performed during the routine preoperative visit, the second session will be performed during the routine postoperative DBS programming visit in both the DBS on and the DBS off settings.

Electromagnetic tracking

Intervention Type DEVICE

The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.

Tremor kinetics before and after DBS

Intervention Type PROCEDURE

We will perform two testing sessions: the first session will be performed during a routine preoperative visit, the second session will be performed during a routine postoperative DBS programming visit in both the DBS on and the DBS off settings.

Interventions

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Electromagnetic tracking

The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.

Intervention Type DEVICE

Tremor kinetics after DBS

We will fit the patient with the electromagnetic sensors and then perform routine outpatient neurologic examinations with their DBS system in both the DBS on and the DBS off settings.

Intervention Type PROCEDURE

Tremor kinetics before and after DBS

We will perform two testing sessions: the first session will be performed during a routine preoperative visit, the second session will be performed during a routine postoperative DBS programming visit in both the DBS on and the DBS off settings.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults
* Individuals who have undergone or are scheduled to undergo Deep Brain Stimulation (DBS) placement

Exclusion Criteria

* Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS) placement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seth Oliveria, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201500964

Identifier Type: -

Identifier Source: org_study_id