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Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

NCT02120690 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-23

No results posted yet for this study

Summary

To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS) for fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation circuitry. The investigators hypothesized that patients with fibromyalgia might experience a clinically significant reduction in daily pain if investigators were to administer TNS in a manner similar to experimental antidepressant protocols.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Trigeminal nerve stimulation

10-day TNS interventional protocol over an 10-day follow-up. Subjects will have electrodes (Superior Silver 1.25-in. diameter) placed on their foreheads to stimulate the V1 branches of the trigeminal nerve bilaterally for approximately 30 minutes each day. Current was adjusted to maintain comfortable but perceptible levels of stimulation

Sponsors & Collaborators

  • Santa Casa Medical School

    lead OTHER

Principal Investigators

  • Pedro Shiozawa, MD · Clinical Neuromodulation Laboratory - Santa Casa Medical School

  • Marcelo V Perez, MD, PhD · Department of Anestesiology - ISCMSP

  • Quirino Corderio, MD, PhD · Department of Psychiatry - ISCMSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120690 on ClinicalTrials.gov