Trial record 51 of 119 for:    fibromyalgia | Open Studies | Interventional Studies

Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia (TNS-FMA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Santa Casa Medical School
Sponsor:
Information provided by (Responsible Party):
Pedro Shiozawa, Santa Casa Medical School
ClinicalTrials.gov Identifier:
NCT02120690
First received: April 20, 2014
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Device: Trigeminal nerve stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study

Resource links provided by NLM:


Further study details as provided by Santa Casa Medical School:

Primary Outcome Measures:
  • VAS for pain [ Time Frame: 10 day-follow up ] [ Designated as safety issue: No ]
    Comparison between VAS for pain after intervention protocol and baseline score


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trigeminal nerve stimulation - active
10-day TNS interventional protocol over an 10-day follow-up
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
Other Name: Trigeminal nerve stimulation
Sham Comparator: Trigeminal nerve stimulation
10-day sham interventional protocol over an 10-day follow-up
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
Other Name: Trigeminal nerve stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120690

Locations
Brazil
Centro de Atencao Integrada à Saúde Mental Not yet recruiting
sao Paulo, sP, Brazil, 04017030
Contact: Pedro Shiozawa, MD    55 11 34662100    pedroshiozawa@gmail.com   
Contact: Pedro Shiozawa         
Principal Investigator: Pedro Shiozawa         
Sponsors and Collaborators
Santa Casa Medical School
Investigators
Study Director: Pedro Shiozawa, MD Clinical Neuromodulation Laboratory - Santa Casa Medical School
Principal Investigator: Marcelo V Perez, MD, PhD Department of Anestesiology - ISCMSP
Study Chair: Quirino Corderio, MD, PhD Department of Psychiatry - ISCMSP
  More Information

Publications:
Responsible Party: Pedro Shiozawa, Coordinator - Laboratory of Clinical Neuromodualtion, Santa Casa Medical School
ClinicalTrials.gov Identifier: NCT02120690     History of Changes
Other Study ID Numbers: TNS-FMA
Study First Received: April 20, 2014
Last Updated: April 22, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Santa Casa Medical School:
pain
fibromyagia
TNS

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 03, 2015