Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Trigeminal nerve stimulation - active

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

Group Type EXPERIMENTAL

Trigeminal nerve stimulation

Intervention Type 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

Trigeminal nerve stimulation

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

Group Type SHAM_COMPARATOR

Trigeminal nerve stimulation

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No