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The objective of this study is to compare the effects of image-guided programming algorithm using various image segmentations vs standard clinical programming on reduction of tremor and patient satisfaction.
At your first visit (Visit 1), your DBS device will be temporarily switched off. The study team 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. Your 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, you 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, we will set your device to one of the programming settings (either image-guided or clinical-based) at random ("Program A"). You will be on this setting for one week, and then we will call you (Phone Call 1) and ask you to switch to the other setting ("Program B") for one week. After this second week, we will call you again (Phone Call 2) and ask which setting you prefer. At that time, you will be free to utilize the setting you preferred for the next two weeks. You will then come in for your Visit 2 after four total weeks (Program A for one week, Program B for one week, and your preferred setting for two weeks).
At Visit 2, we will evaluate the outcomes of your programming optimization. The tremor assessments will be performed again (accelerometer and CRST). The quality-of-life assessment (QUEST) will be administered as well. We will also capture your impression of change and overall level of satisfaction using the Patient Global Impression of Change (PGIC) scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program A | Other | clinical-based standard settings |
|
| Program B | Experimental | Image-guided programming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| programming a | Device | clinical based programming parameters |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor severity as measured by accelerometry | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical measure of tremor severity - CRST | Clinical measure of tremor severity - CRST | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 3. Patient Global Impression of Change (PGIC) Scale | 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) |
Inclusion Criteria:
• Patients from 21-85 years of age
Exclusion Criteria:• Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella R Maze, BS | Contact | 215-829-6720 | gabriella.maze@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurosurgery Department Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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On the study day, DBS will be temporarily switched off to obtain baseline tremor measurements. Tremor severity will be assessed using both quantitative accelerometry and standardized clinical rating scales. Participants will then undergo testing with two different DBS programming approaches: (1) their current clinically optimized program, and (2) an image-guided programming approach informed by VIM segmentation from established neuroanatomical atlases and reported DBS "sweet spots".
For each programming condition, tremor severity will be assessed using accelerometry and clinical rating scales. At the conclusion of testing, both programs will be loaded onto the patient's device, and participants will be instructed to use each program for one week, and the patient can then select the desired program for the following two weeks.
At the 1-month follow-up visit, participants will return for assessment of: (1) total time spent on each program, (2) patient preference for one program over t
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| programming b |
| Device |
image-guided programming parameters |
|
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 |