Neurosurgery Department Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106, United States
NCT Number: NCT07433699
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.
Trial opening soon.
Get Notified21 year–85 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19106, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
• Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent
-
clinical based programming parameters
image-guided programming parameters
Time frame: 1 Month
Time frame: 1 month
Clinical measure of tremor severity - CRST
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.
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
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
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