Image-Guided DBS Programming
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At the participant's first visit (Visit 1), their DBS device will be temporarily switched off. The investigators will then perform a baseline tremor assessment, utilizing the standard methods of an accelerometer (a device to measure acceleration of movement) and the Clinical Rating Scale for Tremor (CRST). A qualify of life assessment will also be administered using the standard Quality of Life in Essential Tremor (QUEST) questionnaire. The participant's device will first be programmed with either the image-guided programming settings or the clinical-based programming settings. Then, it will be switched to the other setting after tremor assessments are completed. Under each setting, the participant will repeat the tremor assessments via accelerometer and the CRST. This will total three tremor assessments during the visit - one for baseline, one for the first setting, and one for the second setting.
After Visit 1, the investigators will set the participant's device to one of the programming settings (either image-guided or clinical-based) at random ("Program A"). The participant will be on this setting for one week, and then the investigators will call the participant (Phone Call 1) and ask them to switch to the other setting ("Program B") for one week. After this second week, the investigators will call the participant again (Phone Call 2) and ask which setting they prefer. At that time, the participant will be free to utilize the setting they preferred for the next two weeks. The participant will then come in for their Visit 2 after four total weeks (Program A for one week, Program B for one week, and the participant's preferred setting for two weeks).
At Visit 2, the investigators will evaluate the outcomes of programming optimization. The tremor assessments will be performed again (accelerometer and CRST). The quality-of-life assessment (QUEST) will be administered as well. The investigators will also capture the participant's impression of change and overall level of satisfaction using the Patient Global Impression of Change (PGIC) scale.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabriella R Maze, BS
- Phone Number: 215-829-6720
- Email: gabriella.maze@pennmedicine.upenn.edu
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Neurosurgery Department Pennsylvania Hospital
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Contact:
- Gabriella R Maze, BS
- Phone Number: 215-829-6720
- Email: gabriella.maze@pennmedicine.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients from 21-85 years of age
- ET patients implanted with Boston Scientific DBS electrodes in the VIM thalamus
- Proficiency with the English Language
- Participant is able to comply with all testing and follow-up requirements as defined by the study protocol
- Participant is able to provide voluntary decisionally capable, and appropriately informed consent
Exclusion Criteria:• Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Program A
clinical-based standard settings
|
clinical based programming parameters
|
|
Experimental: Program B
Image-guided programming
|
image-guided programming parameters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tremor severity as measured by accelerometry
Time Frame: 1 Month
|
1.
The Xsens MTw Awinda accelerometer will be used to measure tremor severity.
Measurements will be taken at baseline (DBS off) and after each stimulation setting.
The accelerometry data can be objectively measured by quantifying the frequency and amplitude of the tremors and has been shown to correlate with the CRST.
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical measure of tremor severity - CRST
Time Frame: 1 month
|
Clinical measure of tremor severity - CRST
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3. Patient Global Impression of Change (PGIC) Scale
Time Frame: 1 month
|
PGIC is a 7-point scale depicting a patient's rating of overall improvement.
Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse.
|
1 month
|
|
4. Quality of Life in Essential Tremor Questionnaire (QUEST)
Time Frame: 1 month
|
The Quality of Life in Essential Tremor Questionnaire (QUEST) is a 30-item scale developed for patients with ET to measure the impact of ET on perceived quality of life (QOL), including activities of daily living that are affected by ET, such as the ability to read and write.
The 30 items contribute to five scales: Physical/ADL, Psychosocial, Communication, Hobbies/Leisure, and Work/Finances.
The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 860081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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