Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

High-definition Transcranial Electrical Stimulation for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550598
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Ministry of Health and Welfare
Information provided by (Responsible Party):
Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: HD-tCES Device: Sham HD-tCES Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: HD-tCES
The experiment group will receive active HD-tCES.
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 Comparator: Sham HD-tCES
The sham control group will receive sham HD-tCES.
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.




Primary Outcome Measures :
  1. Change from baseline in the Numerical Rating Scale (NRS) after intervention [ 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) ]
    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).

  2. Change from baseline in the Impact Questionnaire (FIQ) after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    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 :
  1. Change from baseline pressure pain threshold after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    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.

  2. Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    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.

  3. Change from baseline in the Beck Anxiety Inventory (BAI) after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    The BAI is a 21-question multiple-choice self-report inventory that measures the severity of anxiety.

  4. Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    The PSQI is a 19-item self-report questionnaire that assesses sleep quality.

  5. Change from baseline Tau protein & beta amyloid protein after intervention [ Time Frame: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session) ]
    Tau protein and beta amyloid protein can be the biomarkers of the patient's sleep quality.

  6. Incidence of treatment-emergent adverse events [ Time Frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks) ]
    Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550598


Contacts
Layout table for location contacts
Contact: Juinn-Horng Kang, PhD +886-2-27372181 ext 3538 jhk@tmu.edu.tw

Locations
Layout table for location information
Taiwan
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Juinn-Horng Kang, PhD    +886-2-27372181 ext 3538    jhk@tmu.edu.tw   
Principal Investigator: Juinn-Horng Kang, PhD         
Sub-Investigator: Shih-Ching Chen, PhD         
Sponsors and Collaborators
Taipei Medical University
Ministry of Health and Welfare
Layout table for additonal information
Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT04550598    
Other Study ID Numbers: N202004140
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University:
Fibromyalgia
Transcranial electrical stimulation
Analgesic effect
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases