Image-Guided DBS Programming

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Essential Tremor
• Intervention / Treatment: Device: programming a; Device: programming b

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gabriella R Maze, BS; Phone Number: 215-829-6720; Email: gabriella.maze@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • Neurosurgery Department Pennsylvania Hospital
      • 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: No

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Program A; clinical-based standard settings	Device: programming a; clinical based programming parameters
Experimental: Program B; Image-guided programming	Device: programming b; image-guided programming parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical measure of tremor severity - CRST	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	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)	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: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Essential Tremor; DBS; programming device
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Essential Tremor
• Other Study ID Numbers: 860081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No