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High-definition Transcranial Electrical Stimulation for Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

HD-tCES

Sham HD-tCES

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Transcranial electrical stimulation, Analgesic effect

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HD-tCES

Sham HD-tCES

Arm Description

The experiment group will receive active HD-tCES.

The sham control group will receive sham HD-tCES.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Incidence of treatment-emergent adverse events

Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.

Full Information

NCT ID

NCT04550598

First Posted

August 20, 2020

Last Updated

April 12, 2023

Sponsor

Taipei Medical University

Collaborators

Ministry of Health and Welfare

1. Study Identification

Unique Protocol Identification Number

NCT04550598

Brief Title

High-definition Transcranial Electrical Stimulation for Fibromyalgia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

August 19, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Medical University

Collaborators

Ministry of Health and Welfare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Transcranial electrical stimulation, Analgesic effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HD-tCES

Arm Type

Experimental

Arm Description

The experiment group will receive active HD-tCES.

Arm Title

Sham HD-tCES

Arm Type

Sham Comparator

Arm Description

The sham control group will receive sham HD-tCES.

Intervention Type

Device

Intervention Name(s)

HD-tCES

Intervention Description

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

Intervention Name(s)

Sham HD-tCES

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in the Numerical Rating Scale (NRS) after intervention

Description

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).

Time Frame

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)

Title

Change from baseline in the Impact Questionnaire (FIQ) after intervention

Description

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.

Time Frame