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NCT05096572 · ClinicalTrials.gov registry record · NA
DBS of Posterior Subthalamic Area (PSA) and Ventral Intermediate Nucleus (VIM) in Essential Tremor (ET)
A NA study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT05096572 is a NA study that was terminated before completion, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 1 participants.
The verdict
NCT05096572, a NA study, was terminated before completion, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM) is an FDA approved treatment for medication refractory essential tremor (ET). However, VIM stimulation can be associated with impacts on speech and balance. There is also suggestion that there may be habituation to stimulation in more than half of these patients. Stimulation of the posterior subthalamic area (PSA) has been found to be beneficial in tremor control as well. In fact, there is thought that the improvement in tremor in standard VIM DBS stimulation may be related to stimulation effects on the PSA. Updates in DBS stimulation allow to stimulate more than one area of the brain independently, while using a single lead. In this study, we will recruit patient who are referred for VIM DBS to a randomized cross-over trial in which they will receive VIM, PSA, or dual stimulation. We will assess tremor qualitatively and quantitatively, in addition to evaluating side effects, including quantitative gait analysis on each setting. The pre-operative, operative, and initial programming evaluation will be performed per standard of care. After baseline assessment and initial programming, subjects will be evaluated in a blinded manner after they have been on each setting for 2 weeks. The entire duration of the study from baseline visit through final study visit will be 17 weeks. For subjects who are clinically evaluated in our outpatient clinics, we will review their charts at 6 months for stimulation parameters and clinical information as it relates to their tremor.
Interventions
- DEVICE VIM Stimulation
- DEVICE PSA Stimulation
- DEVICE VIM+PSA Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2023-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05096572
The ClinicalTrials.gov registry entry for NCT05096572 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which VIM Stimulation is the first listed.
NCT05096572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05096572 about?
NCT05096572 is a clinical study titled "DBS of Posterior Subthalamic Area (PSA) and Ventral Intermediate Nucleus (VIM) in Essential Tremor (ET)". Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM) is an FDA approved treatment for medication refractory essential tremor (ET). However, VIM stimulation can be associated with impacts on speech and balance. There is also suggestion that there may be habituation t...
What is the current status of trial NCT05096572?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2021-11-30. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT05096572?
The interventions under investigation include: VIM Stimulation (DEVICE), PSA Stimulation (DEVICE), VIM+PSA Stimulation (DEVICE).
Who is sponsoring clinical trial NCT05096572?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
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