Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- VAS for pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Trigeminal nerve stimulation - active
10-day TNS interventional protocol over an 10-day follow-up
Intervention: Trigeminal nerve stimulation (Device)
Trigeminal nerve stimulation
10-day sham interventional protocol over an 10-day follow-up
Intervention: Trigeminal nerve stimulation (Device)
Outcomes
Primary Outcomes
VAS for pain
Time Frame: 10 day-follow up
Comparison between VAS for pain after intervention protocol and baseline score
Secondary Outcomes
No secondary outcomes reported
Investigators
Pedro Shiozawa
Coordinator - Laboratory of Clinical Neuromodualtion
Santa Casa Medical School