Clinical trial NCT02120690: Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia
Official title: Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: pain
fibromyagia
TNS
Lead sponsor: Santa Casa Medical School
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: VAS for pain
timeFrame: 10 day-follow up
Secondary outcomes:
Other outcomes:
Locations:
city: sao Paulo
country: Brazil
facility: Centro de Atencao Integrada à Saúde Mental
state: sP
Study officials:
affiliation: Clinical Neuromodulation Laboratory - Santa Casa Medical School
name: Pedro Shiozawa, MD
role: STUDY_DIRECTOR
affiliation: Department of Anestesiology - ISCMSP
name: Marcelo V Perez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry - ISCMSP
name: Quirino Corderio, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.