Health TrialsbyHealthPanel

Image-Guided DBS Programming

ConditionEssential Tremor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • programming a

    Device

    clinical based programming parameters

  • programming b

    Device

    image-guided programming parameters

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Program AOther 1 intervention
Group B: Program BExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 Month

Secondary outcomes

1

Clinical measure of tremor severity - CRST

Clinical measure of tremor severity - CRST

Time frame
1 month

Other outcomes

1

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.

Time frame
1 month
2

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

Time frame
1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: