Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trigeminal nerve stimulation - active | Experimental | 10-day TNS interventional protocol over an 10-day follow-up |
|
| Trigeminal nerve stimulation | Sham Comparator | 10-day sham interventional protocol over an 10-day follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigeminal nerve stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS for pain | Comparison between VAS for pain after intervention protocol and baseline score | 10 day-follow up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pedro Shiozawa, MD | Clinical Neuromodulation Laboratory - Santa Casa Medical School | Study Director |
| Marcelo V Perez, MD, PhD | Department of Anestesiology - ISCMSP | Principal Investigator |
| Quirino Corderio, MD, PhD | Department of Psychiatry - ISCMSP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atencao Integrada à Saúde Mental | São Paulo | São Paulo | 04017030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21794655 | Background | 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. | |
| 23819466 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 21764215 | Background | 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. |
| 12759293 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |