High-definition Transcranial Electrical Stimulation for Fibromyalgia

NCT ID: NCT04550598

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2020-12-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HD-tCES

The experiment group will receive active HD-tCES.

Group Type: EXPERIMENTAL

HD-tCES

Intervention Type: 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

The sham control group will receive sham HD-tCES.

Group Type: SHAM_COMPARATOR

Sham HD-tCES

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Welfare

AMBIG

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202004140

Identifier Type: -

Identifier Source: org_study_id