TremorNCT02641366
Electromagnetic Tracking to Measure Tremor
An observational study of Tremor, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tremor
- What is being tested?
- Electromagnetic tracking, Tremor kinetics after DBS and Tremor kinetics before and after DBS
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults
- Individuals who have undergone or are scheduled to undergo Deep Brain Stimulation (DBS) placement
Who cannot join
- Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS) placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
Official title: 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.
Read the 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.
- Conditions
- Tremor
- Being tested
- Electromagnetic tracking, Tremor kinetics after DBS, Tremor kinetics before and after DBS
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic trackingDevice
The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.
Tremor kinetics after DBSProcedure or surgery
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 DBSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Electromagnetic tracking; Procedure: Tremor kinetics before and after DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Oliveria, MD,PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641366
- Sponsor's protocol ID
- IRB201500964
- Status last verified
- Oct 2017
- First submitted
- 14 Dec 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Electromagnetic Tracking of Upper Extremity Motion Kinetics for Patients With Severe Tremor Disorders
- ClinicalTrials.gov ID
- NCT02641366
- Acronym / sponsor ID
- IRB201500964
- Conditions
- Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tremor kinetics after DBS | – | Device: Electromagnetic tracking, Procedure: Tremor kinetics after DBSThis 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. |
| Tremor kinetics before and after DBS | – | Device: Electromagnetic tracking, Procedure: Tremor kinetics before and after DBSThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults
- Individuals who have undergone or are scheduled to undergo Deep Brain Stimulation (DBS) placement
Key exclusion criteria (1 listed)
- Individuals who have not had or are not scheduled for Deep Brain Stimulation (DBS) placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic trackingThe electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination. | Device | Tremor kinetics after DBS, Tremor kinetics before and after DBS |
| Tremor kinetics after DBSWe 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. | Procedure or surgery | Tremor kinetics after DBS |
| Tremor kinetics before and after DBSWe 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. | Procedure or surgery | Tremor kinetics before and after DBS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Oliveria, MD,PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tremor, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectrum peaks (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.