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Completed

NCT Number: NCT04550598

High-definition Transcranial Electrical Stimulation for Fibromyalgia

Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. The investigators developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, the investigators will preliminarily examine the effects and safety of the HD-tCES in patients with fibromyalgia. The investigators expect that the HD-tCES will relief pain, improve sleep quality, emotion, and general health of the patients.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With a diagnosis of fibromyalgia.
  • Age ≥ 20 years.
  • A mean pain score ≥ 4 on a 11-point numeric rating scale during the 2 weeks preceding the trial.

Exclusion criteria

  • Intolerance to electrical stimulation.
  • A history of arrhythmia.
  • Implantable medical electronic devices (e.g., like pacemaker).
  • Metal implants in the head or neck.
  • Wounds on the skin of head.
  • A history of brain surgery or severe brain trauma.
  • Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
  • A history of seizure or other brain pathology.
  • Drug or alcohol abuse.
  • Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
  • Pregnancy.
  • Change in medication of fibromyalgia within 1 week prior the trial.
  • Pregnant or breastfeeding women.
  • Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
  • History of encephalitis or meningitis.

Treatment and study plan

HD-tCES

Device

The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The electrode will be applied at the left M1 or contralateral to pain side. The anodal electrode was placed on the C3/C4, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 5 times a week, lasting for 2 weeks.

Sham HD-tCES

Device

The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The electrode will be applied at the left M1 or contralateral to pain side. The anodal electrode was placed on the C3/C4, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.

Primary outcomes

  1. Change from baseline in the Numerical Rating Scale (NRS) after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session), each intervention session in 2 weeks, and after 2-week intervention (within 7 days after the last intervention session)

    The NRS is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain).

  2. Change from baseline in the Impact Questionnaire (FIQ) after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    The FIQ is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being.

Secondary outcomes

  1. Change from baseline pressure pain threshold after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    The pressure pain threshold is defined as the minimum force applied which induces pain. The pressure pain threshold of bilateral trapeziuses, lateral epicondyle of humeri, greater trochanters, and knees will be measured.

  2. Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    The BDI-II is a 21-item self-report questionnaire that measures major depression symptoms according to diagnostic criteria listed in the Diagnostic and Statistical Manual for Mental Disorders.

  3. Change from baseline in the Beck Anxiety Inventory (BAI) after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    The BAI is a 21-question multiple-choice self-report inventory that measures the severity of anxiety.

  4. Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    The PSQI is a 19-item self-report questionnaire that assesses sleep quality.

  5. Change from baseline Tau protein & beta amyloid protein after intervention

    Time frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)

    Tau protein and beta amyloid protein can be the biomarkers of the patient's sleep quality.

  6. Incidence of treatment-emergent adverse events

    Time frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)

    Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Ministry of Health and Welfare

Registry information

Official study title

Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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