Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

— TNS-FMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02120690
• Other study ID #: TNS-FMA
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 20, 2014
• Last updated: April 22, 2014
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2014
• Source: Santa Casa Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro de Atencao Integrada à Saúde Mental	sao Paulo	sP

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa Medical School

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View Citation

Short EB, 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):2477-84. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20. — View 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. Erratum in: Mol Pain. 2014;10:16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS for pain	Comparison between VAS for pain after intervention protocol and baseline score	10 day-follow up	No