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NCT02495883 · ClinicalTrials.gov registry record · Phase 4
Functional Imaging of Tremor Circuits and Mechanisms of Treatment Response
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT02495883 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 56 participants.
The verdict
NCT02495883, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
Essential Tremor (ET) is the most common tremor disorder, currently affecting an estimated 2.9 million Americans and leading to disability and decreased quality of life in 75% of cases. The pathophysiology of ET is poorly understood, with the source of the tremor remaining controversial since all studies show increased activity in the cerebellum (including mimicked tremor in controls), while animal models of ET using harmaline and a single human PET study implicate the inferior olivary nucleus in the brainstem. There is evidence from the investigator's laboratory that the use of resting-state functional magnetic resonance imaging (rs-fMRI) is useful for characterizing the abnormal tremor neural network in ET compared with controls. The goal is to identify the source of the tremor, which is hypothesized to remain active during rest. Current ET diagnostic criteria require the presence of postural and/or kinetic tremor, which are assumed to be different manifestations of the same tremor oscillator. This long-standing assumption may be incorrect based on several lines of evidence from the investigator's laboratory, and has major implications for understanding ET pathophysiology and treatment. The investigators will test the hypothesis that postural and kinetic tremors are generated through different neural mechanisms. Treatment of ET focuses on pharmacological agents of various mechanisms and rarely deep brain stimulation of the Vim thalamus. Despite the assortment of agents used to treat ET, only \~50% of patients benefit from a particular agent. Furthermore, the mechanisms of action on tremor are not generally known. Understanding the mechanisms of action of various tremor-suppressing agents is critical for future drug development. In this proposal, the investigators plan to study the effects of ethanol (the most efficacious tremor-suppressant currently available) and propranolol (a non-specific β-adrenergic blocker with proven efficacy and unknown mechanism of act
Interventions
- DRUG Propranolol
- OTHER Ethanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02495883
The ClinicalTrials.gov registry entry for NCT02495883 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Propranolol is the first listed.
NCT02495883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02495883 about?
NCT02495883 is a clinical study titled "Functional Imaging of Tremor Circuits and Mechanisms of Treatment Response". Essential Tremor (ET) is the most common tremor disorder, currently affecting an estimated 2.9 million Americans and leading to disability and decreased quality of life in 75% of cases. The pathophysiology of ET is poorly understood, with the source of the tremor remaining controversial since all st...
What is the current status of trial NCT02495883?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2013-12. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02495883?
The interventions under investigation include: Propranolol (DRUG), Ethanol (OTHER).
Who is sponsoring clinical trial NCT02495883?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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