---
title: Neurostimulation Applied to Fibromyalgia
nct_id: NCT03384888
overall_status: UNKNOWN
phase: NA
sponsor: Federal University of Paraíba
study_type: INTERVENTIONAL
primary_condition: Fibromyalgia
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03384888.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03384888"
ct_last_update_post_date: 2019-01-23
last_seen_at: "2026-05-12T07:01:19.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Neurostimulation Applied to Fibromyalgia

**NCT ID:** [NCT03384888](https://clinicaltrials.gov/study/NCT03384888)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 59
- **Lead Sponsor:** Federal University of Paraíba
- **Conditions:** Fibromyalgia
- **Start Date:** 2017-05-15
- **Completion Date:** 2020-05
- **CT.gov Last Update:** 2019-01-23

## Brief Summary

NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 60 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
* (2) been diagnosed for at least three months;
* (3) be female;
* (4) be in the age group between 25 and 60 years of age; and
* (5) sign the consent form.

Exclusion Criteria:

* (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
* (2) illiterate;
* (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
* (4) history of convulsion;
* (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
* (6) be pregnant.
```

## Arms

- **ano-M1-cat-SO5 tDCS** (EXPERIMENTAL) — Participants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days.
- **ano-M1-cat-SO10 tDCS** (EXPERIMENTAL) — Participants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days.
- **Sham tDCS** (SHAM_COMPARATOR) — Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.

## Interventions

- **Active tDCS** (DEVICE) — Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.
- **Sham tDCS** (DEVICE) — Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.

## Primary Outcomes

- **Pain intensity level** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_ — Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain.

## Secondary Outcomes

- **Quality of life level** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Health assessment level** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Sleep quality** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Cognitive function** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Anxiety level** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Depression level** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Cortical electrical activity** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_
- **Resilience** _(time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))_

## Locations (1)

- Universidade Federal da Paraiba, João Pessoa, Paraíba, Brazil

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universidade federal da paraiba|joão pessoa|paraíba|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03384888.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03384888*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*
