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Effects of neuromodulation in women with fibromyalgia

Effects of neuromodulation on electroencephalographic activity in fibromyalgia patients and comparison with healthy ones

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-6w2vtp
Enrollment
Unknown
Registered
2020-07-20
Start date
2018-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

Transcranial direct current stimulation (ETCC) complementary to the kinesiotherapy protocol in women with fibromyalgia (FM). ETCC for 20 minutes and kinesiotherapy for 50 minutes. Participants will be
Group 2 (15 participants), anodic stimulation over the left dorsolateral prefrontal cortex and cathodic stimulation over the right supraorbital during and sham group (15 participants), following the p
Other
E02.331.750
H02.010.625

Sponsors

Universidade Federal da Paraíba
Lead Sponsor
Programa de Pós-graduação em Neurociência Cognitiva e Comportamento
Collaborator

Eligibility

Sex/Gender
Female
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: Have a diagnosis of fibromyalgia according to the criteria of the American College of Reumathology; Having been diagnosed at least three months ago; Being female; Be in the age group between 35 and 60 years old; Present a pain level above four on the visual analog scale; Sign the Free and Informed Consent Form.

Exclusion criteria

Exclusion criteria: Score below 24 on the Mini Mental State Examination; illiterate; have metallic implants located on the head or cochlear implants or cardiac pacemaker; being pregnant; have a history of seizure.

Design outcomes

Primary

MeasureTime frame
Pain intensity, assessed by visual analog scale. The scale consists of a horizontal line of 10 cm, in which there are graduations ranging from zero to 10, and the participants point out a point that for them best represents their perception of pain intensity, with (0) being in absence of pain, (1-3) mild, (4-7) moderate and (8-10) severe pain.

Secondary

MeasureTime frame
Cortical electrical activity, assessed by electroencephalogram (EEG). The EEG used has 32 channels, with silver chloride electrodes, which will be fixed to the scalp through an adjustable cap. The amplifier is the ActiChamp, developed by Brain Products Inc., with a sampling rate of 500Hz.

Countries

Brazil

Contacts

Public ContactNelson Torro

Universidade Federal da Paraíba

nelsontorro@gmail.com+55 83 32167136

Outcome results

None listed

Source: REBEC (via WHO ICTRP)