NCT02120690

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

April 20, 2014

Last Update Submit

April 22, 2014

Conditions

Fibromyalgia

Keywords

painfibromyagiaTNS

Outcome Measures

Primary Outcomes (1)

  • VAS for pain

    Comparison between VAS for pain after intervention protocol and baseline score

    10 day-follow up

Study Arms (2)

Trigeminal nerve stimulation - active

EXPERIMENTAL

10-day TNS interventional protocol over an 10-day follow-up

Device: Trigeminal nerve stimulation

Trigeminal nerve stimulation

SHAM COMPARATOR

10-day sham interventional protocol over an 10-day follow-up

Device: Trigeminal nerve stimulation

Interventions

Trigeminal nerve stimulationDEVICE

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

Trigeminal nerve stimulationTrigeminal nerve stimulation - active

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Atencao Integrada à Saúde Mental

São Paulo, São Paulo, 04017030, Brazil

Location

Related Publications (4)

  • Collado A, Conesa A. [Pharmacologic treatment of fibromyalgia: Towards chemical neuromodulation]. Reumatol Clin. 2009 Aug;5 Suppl 2:27-31. doi: 10.1016/j.reuma.2009.04.003. Epub 2009 Jul 9. Spanish.

    PMID: 21794655BACKGROUND

  • Tzabazis A, Aparici CM, Rowbotham MC, Schneider MB, Etkin A, Yeomans DC. Shaped magnetic field pulses by multi-coil repetitive transcranial magnetic stimulation (rTMS) differentially modulate anterior cingulate cortex responses and pain in volunteers and fibromyalgia patients. Mol Pain. 2013 Jul 2;9:33. doi: 10.1186/1744-8069-9-33.

    PMID: 23819466BACKGROUND

  • Short BE, Borckardt JJ, Anderson BS, Frohman H, Beam W, Reeves ST, George MS. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: a randomized, controlled pilot study. Pain. 2011 Nov;152(11):2477-2484. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.

    PMID: 21764215BACKGROUND

  • Ozgocmen S, Yoldas T, Kamanli A, Yildizhan H, Yigiter R, Ardicoglu O. Auditory P300 event related potentials and serotonin reuptake inhibitor treatment in patients with fibromyalgia. Ann Rheum Dis. 2003 Jun;62(6):551-5. doi: 10.1136/ard.62.6.551.

    PMID: 12759293BACKGROUND

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro Shiozawa, MD

    Clinical Neuromodulation Laboratory - Santa Casa Medical School

    STUDY DIRECTOR

  • Marcelo V Perez, MD, PhD

    Department of Anestesiology - ISCMSP

    PRINCIPAL INVESTIGATOR

  • Quirino Corderio, MD, PhD

    Department of Psychiatry - ISCMSP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator - Laboratory of Clinical Neuromodualtion

Study Record Dates

First Submitted

April 20, 2014

First Posted

April 23, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

BR(1)