Electromagnetic Tracking to Measure Tremor

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02641366
Collaborator
(none)
20
1
11
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Electromagnetic tracking
  • Procedure: Tremor kinetics after DBS
  • Procedure: Tremor kinetics before and after DBS

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Noninvasive Electromagnetic Tracking of Upper Extremity Motion Kinetics for Patients With Severe Tremor Disorders
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

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

Procedure: 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.

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.

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

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.

Outcome Measures

Primary Outcome Measures

  1. Power spectrum peaks [1 day]

    We will perform power spectrum analysis of raw movement data (X, Y, Z coordinates at each time point). Spectral analysis will be used to differentiate multiple underlying components of a patient's tremor that occur at different frequencies.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Movement Disorders and Neurorestoration Gainesville Florida United States 32607

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Seth Oliveria, MD,PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02641366
Other Study ID Numbers:
  • IRB201500964
First Posted:
Dec 29, 2015
Last Update Posted:
Oct 26, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2017