NCT02120690

Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Santa Casa Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-04-23
• Last updated: 2014-04-23

Locations

1 site across 1 country: Brazil