Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia (TNS-FMA)

Santa Casa Medical School

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Fibromyalgia

Treatments

Device: Trigeminal nerve stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02120690

TNS-FMA

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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.