Image-Guided DBS Programming

University of Pennsylvania

Status: Not yet enrolling

Conditions: Essential Tremor

Treatments: Device: programming a; Device: programming b

Study type: Interventional

Funder types: Other

Identifiers

NCT07433699

860081

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Program A

Other group

Description:

clinical-based standard settings

Treatment:

Device: programming a

Program B

Experimental group

Description:

Image-guided programming

Treatment:

Device: programming b