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NCT01745003 · ClinicalTrials.gov registry record · Phase 1

Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia

A Phase 1 study, sponsored by University of Michigan.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01745003 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 13 participants.

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The verdict

NCT01745003, a Phase 1 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The main goal of this Collaborative Proposal is to investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities which focus on central mechanisms provide modest relief for these patients raises the possibility that the cause for the chronicity of this debilitating disorder may lie within the brain itself. We propose that changes in the cortical milieu may result from prolonged experience of pain and suffering. Our previous results suggest changes in excitatory neurotransmitter levels, connectivity between multiple brain networks, and cortical thickness coincide within central neural loci related to pain perception and modulation in FM. Interestingly, modulation of cortical activity can be achieved noninvasively by a novel tool, transcranial direct current stimulation (tDCS), which has been reported to produce lasting therapeutic effects in chronic pain, especially FM. We propose to study the long-term effects of tDCS application on multiple levels of the central nervous system in FM patients. This project has significant clinical relevance and has the support of collaborators from University of Michigan and Harvard University

Interventions

  • PROCEDURE Transcranial Direct Current Stimulation (tDCS)

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2012-03
Est. Completion 2013-09
Phase Phase 1

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT01745003

The ClinicalTrials.gov registry entry for NCT01745003 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 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 Transcranial Direct Current Stimulation (tDCS) is the first listed.

NCT01745003 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01745003 about?

NCT01745003 is a clinical study titled "Effects of Direct Transcranial Current Stimulation on Central Neural Pain Processing in Fibromyalgia". The main goal of this Collaborative Proposal is to investigate biochemical, functional, and structural neuroimaging changes following non-invasive brain stimulation in patients with chronic widespread pain: fibromyalgia (FM). The fact that multiple therapeutic modalities which focus on central mecha...

What is the current status of trial NCT01745003?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-03. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01745003?

The interventions under investigation include: Transcranial Direct Current Stimulation (tDCS) (PROCEDURE).

Who is sponsoring clinical trial NCT01745003?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.