Image-Guided DBS Programming

NCT07433699 | Not Yet Recruiting Phase 1

• 1 other identifier: 860081
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Keywords

Essential Tremor; DBS; programming device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical measure of tremor severity - CRST

  1 month

Other Outcomes (2)

• 3. Patient Global Impression of Change (PGIC) Scale

  1 month

• 4. Quality of Life in Essential Tremor Questionnaire (QUEST)

  1 month

Study Arms (2)

Program A

OTHER

clinical-based standard settings

Device: programming a

Program B

EXPERIMENTAL

Image-guided programming

Device: programming b

Interventions

programming a DEVICE

clinical based programming parameters

Program A

programming b DEVICE

image-guided programming parameters

Program B

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Neurosurgery Department Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Gabriella R Maze, BS

CONTACT

215-829-6720; gabriella.maze@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: 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

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)