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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Trigeminal nerve stimulation
Sponsored by
Santa Casa Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring pain, fibromyagia, TNS

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Atencao Integrada à Saúde Mental

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Trigeminal nerve stimulation - active

Trigeminal nerve stimulation

Arm Description

10-day TNS interventional protocol over an 10-day follow-up

10-day sham interventional protocol over an 10-day follow-up

Outcomes

Primary Outcome Measures

VAS for pain
Comparison between VAS for pain after intervention protocol and baseline score

Secondary Outcome Measures

Full Information

First Posted
April 20, 2014
Last Updated
April 22, 2014
Sponsor
Santa Casa Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02120690
Brief Title
Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia
Acronym
TNS-FMA
Official Title
Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Casa Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
pain, fibromyagia, TNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trigeminal nerve stimulation - active
Arm Type
Experimental
Arm Description
10-day TNS interventional protocol over an 10-day follow-up
Arm Title
Trigeminal nerve stimulation
Arm Type
Sham Comparator
Arm Description
10-day sham interventional protocol over an 10-day follow-up
Intervention Type
Device
Intervention Name(s)
Trigeminal nerve stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS for pain
Description
Comparison between VAS for pain after intervention protocol and baseline score
Time Frame
10 day-follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
Organizational Affiliation
Clinical Neuromodulation Laboratory - Santa Casa Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcelo V Perez, MD, PhD
Organizational Affiliation
Department of Anestesiology - ISCMSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Quirino Corderio, MD, PhD
Organizational Affiliation
Department of Psychiatry - ISCMSP
Official's Role
Study Chair
Facility Information:
Facility Name
Centro de Atencao Integrada à Saúde Mental
City
sao Paulo
State/Province
sP
ZIP/Postal Code
04017030
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
Phone
55 11 34662100
Email
pedroshiozawa@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa

12. IPD Sharing Statement

Citations:
PubMed Identifier
21794655
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.
Results Reference
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PubMed Identifier
23819466
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 Jan-Dec;10:174480691016.
Results Reference
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PubMed Identifier
21764215
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.
Results Reference
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PubMed Identifier
12759293
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.
Results Reference
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Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

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