Essential Tremor
Conditions
Keywords
Essential Tremor, DBS, programming device
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.
Detailed 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.
Interventions
DEVICEprogramming a
clinical based programming parameters
DEVICEprogramming b
image-guided programming parameters
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tremor severity as measured by accelerometry | 1 Month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical measure of tremor severity - CRST | 1 month | Clinical measure of tremor severity - CRST |
Countries
United States
Contacts
CONTACTGabriella R Maze, BS
Outcome results
None listed