NCT07433699

Image-Guided DBS Programming

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	programming a	clinical based programming parameters
DEVICE	programming b	image-guided programming parameters

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States