Electromagnetic Tracking to Measure Tremor
October 24, 2017 updated by: University of Florida
Noninvasive Electromagnetic Tracking of Upper Extremity Motion Kinetics for Patients With Severe Tremor Disorders
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32607
- Center for Movement Disorders and Neurorestoration
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients between 18 and 80 years old who have undergone deep brain stimulator implantation or are being considered for deep brain stimulation for severe, intractable tremor.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.
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.
|
The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Power spectrum peaks
Time Frame: 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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seth Oliveria, MD,PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 14, 2015
First Submitted That Met QC Criteria
December 22, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.