High-definition Transcranial Electrical Stimulation for Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: HD-tCES
* Device: Sham HD-tCES


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD-tCES<br>The experiment group will receive active HD-tCES. | Device: HD-tCES<br>* 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.<br>|
| Sham Comparator: Sham HD-tCES<br>The sham control group will receive sham HD-tCES. | Device: Sham HD-tCES<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Numerical Rating Scale (NRS) after intervention | 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). | 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) | 
| Change from baseline in the Impact Questionnaire (FIQ) after intervention | 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. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pressure pain threshold after intervention | 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. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 
| Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention | 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. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 
| Change from baseline in the Beck Anxiety Inventory (BAI) after intervention | The BAI is a 21-question multiple-choice self-report inventory that measures the severity of anxiety. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 
| Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention | The PSQI is a 19-item self-report questionnaire that assesses sleep quality. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 
| Change from baseline Tau protein & beta amyloid protein after intervention | Tau protein and beta amyloid protein can be the biomarkers of the patient's sleep quality. | Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) | 
| Incidence of treatment-emergent adverse events | Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect. | Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Transcranial electrical stimulation, Analgesic effect