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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: Clinical Trial NA study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tremor will be measured quantitatively using inertial measurement units. FTM-TRS will also be measured by the investigator.
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 |
Why NCT05096572 stopped before completion
NCT05096572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which VIM Stimulation is the first listed.
NCT05096572 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05096572's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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