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NCT01958853 · ClinicalTrials.gov registry record · NA

Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study

A NA study of Fibromyalgia, sponsored by Cerephex Corporation.

Completed
Registry status
NA
Development phase
23
Enrollment target
1
Study location

NCT01958853: Completed NA study of Fibromyalgia, sponsored by Cerephex Corporation.

NCT01958853 is a NA study of Fibromyalgia that has completed, run by Cerephex Corporation. The registered enrollment target is 23 participants, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01958853, a NA study of Fibromyalgia, has completed, sponsored by Cerephex Corporation.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

The purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201 (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol as that used in active treatment arms of NPT-201. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study will provide active treatment to those participants who received sham therapy in NPT-201, and will test whether or not additional therapy applications might further improve pain in those participants who previously received active therapy, but did not achieve adequate pain relief.

Primary Outcome

Pain intensity evaluated on a 100-mm visual analog scale (VAS)

Conditions Studied

Interventions

  • DEVICE RINCE

Study Locations (1)

Michigan

  • St. Joseph Mercy Oakland - Pontiac

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2013-08
Est. Completion 2014-05
Phase NA
Cerephex Corporation

4 total trials

What the finished NCT01958853 record still lists

NCT01958853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 1 intervention - of which RINCE is the first listed.

NCT01958853 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT01958853 about?

NCT01958853 is a clinical study titled "Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study". The purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201 (NCT01825954). The therapy will be...

What is the current status of trial NCT01958853?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2013-08. Estimated completion is 2014-05.

What conditions does trial NCT01958853 study?

This clinical trial studies the following conditions: Fibromyalgia.

What interventions are being tested in trial NCT01958853?

The interventions under investigation include: RINCE (DEVICE).

Who is sponsoring clinical trial NCT01958853?

This trial is sponsored by Cerephex Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01958853 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Fibromyalgia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01958853's enrollment target sits among peer trials

23 68th of 76 higher than 9 of 76 other Fibromyalgia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fibromyalgia 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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Source: ClinicalTrials.gov NCT01958853, the US trial registry maintained by the National Library of Medicine. NCT01958853 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.