Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Phase 1

• Conditions: Fibromyalgia
• Interventions: Device: Trigeminal nerve stimulation

• Registration Number: NCT02120690
• Lead Sponsor: Santa Casa Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-20
• Study First Submitted QC: 2014-04-22
• Last Update Submitted: 2014-04-22
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23
• Study Start: 2014-06
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• We will adopt the following inclusion criteria: (1) patients between 18 and 69 years; (2) patients with a diagnosis of fibromyalgia according to a trained phisycian; (3) score greater than or equal to 5 on the VAS for pain; (4) agreement to participate in the study as recommended in the IC.

Exclusion Criteria

• Exclusion criteria we cite: (1) patients with psychiatric hospitalization indicated; (2) patients with psychiatric comorbidity; (3) patients with a diagnosis of personality disorder; (4) presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic decompensated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trigeminal nerve stimulation	Trigeminal nerve stimulation	10-day sham interventional protocol over an 10-day follow-up
Trigeminal nerve stimulation - active	Trigeminal nerve stimulation	10-day TNS interventional protocol over an 10-day follow-up

Primary Outcome Measures

Name	Time	Method
VAS for pain	10 day-follow up	Comparison between VAS for pain after intervention protocol and baseline score

Trial Locations

Locations (1)

Centro de Atencao Integrada à Saúde Mental; 🇧🇷 sao Paulo, sP, Brazil