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NCT01914679 · ClinicalTrials.gov registry record · NA
A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT01914679 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 17 participants.
The verdict
NCT01914679, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the mechanisms of noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" RINCE)in the management of fibromyalgia. Patients who meet the 1990 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 20 patients will receive a combination of active and inactive (sham) therapy treatments over a 16-week period followed by a 4 week post-treatment evaluation. Patients will also undergo three (3) functional brain imaging scans while participating in the study: the first prior to the commencement of treatment, another mid-treatment; and the third at the completion of the treatment period. The study's primary outcome measure will be the change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a change in pain intensity as well brain functioning. We do not expect there to be a statistically significant improvement in pain intensity due to the small sample but do expect to see statistically significant changes in cortical function as measured by EEG and fMRI
Interventions
- DEVICE RINCE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01914679
The ClinicalTrials.gov registry entry for NCT01914679 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RINCE is the first listed.
NCT01914679 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01914679 about?
NCT01914679 is a clinical study titled "A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan". The purpose of this study is to evaluate the mechanisms of noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" RINCE)in the management of fibromyalgia. Patients who meet the 1990 American College of Rheumatology criteria for fibromyalg...
What is the current status of trial NCT01914679?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2013-07. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01914679?
The interventions under investigation include: RINCE (DEVICE).
Who is sponsoring clinical trial NCT01914679?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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