Essential TremorNCT07433699
Image-Guided DBS Programming
A study testing programming a and programming b in people with Essential Tremor, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- programming a and programming b
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neurosurgery Department Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Gabriella R Maze, BS, 215-829-6720, gabriella.maze@pennmedicine.upenn.edu
About this study
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.
Read the 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.
- Conditions
- Essential Tremor
- Being tested
- programming a, programming b
- Keywords
- Essential Tremor, DBS, programming device
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
programming aDevice
clinical based programming parameters
programming bDevice
image-guided programming parameters
| Study group | Role | What they receive |
|---|---|---|
| Program A | Other | clinical-based standard settings Receives: Device: programming a |
| Program B | Experimental | Image-guided programming Receives: Device: programming b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor severity as measured by accelerometry
- 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.
Measured: 1 Month
Secondary outcomes (1)
Clinical measure of tremor severity - CRST
Clinical measure of tremor severity - CRST
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casey H. Halpern, M.D., University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433699
- Sponsor's protocol ID
- 860081
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided DBS Programming
- ClinicalTrials.gov ID
- NCT07433699
- Acronym / sponsor ID
- 860081
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, DBS, programming device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Program A | Other | Device: programming aclinical-based standard settings |
| Program B | Experimental | Device: programming bImage-guided programming |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Patients from 21-85 years of age
- Exclusion Criteria:• Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| programming aclinical based programming parameters | Device | Program A |
| programming bimage-guided programming parameters | Device | Program B |
Primary outcome
Tremor severity as measured by accelerometry
Time frame: 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.
1 secondary outcome
Clinical measure of tremor severity - CRST
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing programming a and programming b in people with Essential Tremor, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella R Maze, BS (215-829-6720, gabriella.maze@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor severity as measured by accelerometry (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.