High-definition Transcranial Electrical Stimulation for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550598
• Other study ID #: N202004140
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• HD-tCES
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
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)