FibromyalgiaNCT04550598
High-definition Transcranial Electrical Stimulation for Fibromyalgia
A study testing HD-tCES in people with Fibromyalgia, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- HD-tCES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia
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
- Being tested
- HD-tCES, Sham HD-tCES
- Keywords
- Fibromyalgia, Transcranial electrical stimulation, Analgesic effect
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tCESDevice
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-tCESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HD-tCES | Experimental | The experiment group will receive active HD-tCES. Receives: Device: HD-tCES |
| Sham HD-tCES | Sham comparator | The sham control group will receive sham HD-tCES. Receives: Device: Sham HD-tCES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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 outcomes (6)
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.
Measured: 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
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.
Measured: 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
The BAI is a 21-question multiple-choice self-report inventory that measures the severity of anxiety.
Measured: 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
The PSQI is a 19-item self-report questionnaire that assesses sleep quality.
Measured: 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
Tau protein and beta amyloid protein can be the biomarkers of the patient's sleep quality.
Measured: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
Incidence of treatment-emergent adverse events
Immediately after each HD-tCES stimulation, the patient will be questioned about eventual side effect.
Measured: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550598
- Sponsor's protocol ID
- N202004140
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04550598
- Acronym / sponsor ID
- N202004140
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Transcranial electrical stimulation, Analgesic effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD-tCES | Experimental | Device: HD-tCESThe experiment group will receive active HD-tCES. |
| Sham HD-tCES | Sham comparator | Device: Sham HD-tCESThe sham control group will receive sham HD-tCES. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-tCESThe 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. | Device | HD-tCES |
| Sham HD-tCESThe 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. | Device | Sham HD-tCES |
Primary outcome
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).
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.
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tCES in people with Fibromyalgia, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.