Electromagnetic Tracking to Measure Tremor

NCT02641366 | Completed

• 1 other identifier: IRB201500964
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tremor

Outcome Measures

Primary Outcomes (1)

• Power spectrum peaks

  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

Study Arms (2)

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; Procedure: Tremor kinetics after DBS

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; Procedure: Tremor kinetics before and after DBS

Interventions

Electromagnetic tracking 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; Tremor kinetics before and after DBS

Tremor kinetics after DBS 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 after DBS

Tremor kinetics before and after DBS 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.

Tremor kinetics before and after DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS) placement

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seth Oliveria, MD,PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)