Clinical trial NCT04550598: High-definition Transcranial Electrical Stimulation for Fibromyalgia
Official title: Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Transcranial electrical stimulation
Analgesic effect
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare
First posted: 2020-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the Numerical Rating Scale (NRS) after intervention
timeFrame: 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)
measure: Change from baseline in the Impact Questionnaire (FIQ) after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
Secondary outcomes:
measure: Change from baseline pressure pain threshold after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
measure: Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
measure: Change from baseline in the Beck Anxiety Inventory (BAI) after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
measure: Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
measure: Change from baseline Tau protein & beta amyloid protein after intervention
timeFrame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
measure: Incidence of treatment-emergent adverse events
timeFrame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: