High-definition Transcranial Electrical Stimulation for Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: Sham HD-tCES; Device: HD-tCES

• Registration Number: NCT04550598
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham HD-tCES	Sham HD-tCES	The sham control group will receive sham HD-tCES.
HD-tCES	HD-tCES	The experiment group will receive active HD-tCES.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Numerical Rating Scale (NRS) after intervention	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).
Change from baseline in the Impact Questionnaire (FIQ) after intervention	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 Outcome Measures

Name	Time	Method
Change from baseline in the Beck Anxiety Inventory (BAI) after intervention	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.
Change from baseline Tau protein & beta amyloid protein after intervention	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.
Change from baseline pressure pain threshold after intervention	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.
Incidence of treatment-emergent adverse events	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.
Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention	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.
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention	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.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan