High-definition Transcranial Electrical Stimulation for Fibromyalgia

NCT04550598 | Completed

• 1 other identifier: N202004140
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Fibromyalgia; Transcranial electrical stimulation; Analgesic effect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

HD-tCES

EXPERIMENTAL

The experiment group will receive active HD-tCES.

Device: HD-tCES

Sham HD-tCES

SHAM COMPARATOR

The sham control group will receive sham HD-tCES.

Device: Sham HD-tCES

Interventions

HD-tCES 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.

HD-tCES

Sham HD-tCES 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.

Sham HD-tCES

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Health and Welfare: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 16, 2020
• Study Start: August 19, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

TW (1)