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FibromyalgiaPhase 2NCT05321693

Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia

A Phase 2 study testing Transcranial Pulsed Current Stimulation in people with Fibromyalgia, run by Centro Universitario La Salle at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Fibromyalgia (FM) is a functional syndrome characterized by musculoskeletal, diffuse and persistent (> 3 months) chronic pain, that is also characterized by sleep disturbances, fatigue, humor changes and cognitive and psychological changes. Read more about this study

Who is it for?
Ages 30 to 65 years, women only
Conditions the study is for
Fibromyalgia
What is being tested?
Transcranial Pulsed Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesBrazil
Study dates
10 Dec 2021to 10 Dec 2022
Phase
Phase 2
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 30 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women from 30 to 65 years old
  • FM diagnosis according to ACR criteria (2016)
  • Pain on VAS equal to or higher than 6 in the last 3 months
  • Chronic stable treatment over the past 3 months.

Who cannot join

  • Pregnancy or lack of contraceptive use;
  • History of alcohol or drug abuse in the last 6 months,
  • Neurological disorders;
  • Cardiac arrhythmia;
  • Use of drugs that change vascular response;
  • History of head trauma, mild or severe;
Show all 9Show fewer
  • History of neurosurgery;
  • Decompensated systemic diseases;
  • Current diagnosis or history of cancer

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites, 2 recruiting

  • Universidade La Salle

    Canoas, Rio Grande do Sul, 92010-000

    Liciane Fernandes Medeiros, PhD, +5551980502028, licimedeiros@gmail.com

    Liciane Fernandes Medeiros, PhD

    Recruiting

  • Instituto de Neuromodulação e Reabilitação Avançada

    Novo Hamburgo, Rio Grande do Sul, 93520575

    Andressa de Souza, PhD, +5551981975718, andressasz@gmail.com

    Andressa de Souza, PhD

    Recruiting

Other trials in Brazil

About this study

Official title: Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia: a Randomized Clinical Trial, Double-blinded, Controlled With Sham

Fibromyalgia (FM) is a functional syndrome characterized by musculoskeletal, diffuse and persistent (> 3 months) chronic pain, that is also characterized by sleep disturbances, fatigue, humor changes and cognitive and psychological changes. Transcranial Pulsed Current Stimulation (tPCS) is a new Transcranial Electrical Stimulation (tES) that has been studied as a treatment option for chronic pain and neurological conditions . Studies have shown that tPCS is capable of pain and cognitive modulation; however, there are not enough studies with evidenceofits efficacy.Therefore, the primary aim of this study is to evaluate the effects of tPCS in pain, evaluated through Visual Analogue Scale (VAS) in FM patients; besides that, it is aimed to evaluate the effects of tPCS on quality of life, cognitive impairments, pain pressure threshold, descending inhibitory system of pain, and serum levels of Brain Derived Neurotrophic Factor (BDNF) and S100 Calcium-Binding Protein B (S100B). A randomized, double-blinded, controlled with sham clinical trial will be conducted with 70 (Critical f: 2.003; ES: 0.76; alpha: 0.05; power: 0.80) women with Fibromyalgia, from 30 to 65 years with pain on the Visual Analogue Scale (VAS) higher than 6 in the last 3 months. All patients will read and sign an Informed Consent Form (ICF). Each patient will be randomized to either 1+4 sessions of tPCS (2mA, 6-10Hz, 1-20ms, 20-25 minutes) or Sham. Patients will complete the following questionnaires/tests: Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), Fibromyalgia Impact Questionnaire (FIQ), Pain Catastrophizing Scale (PCS), Profile of Chronic Pain (PCP), Conditioned Pain Modulation Task (CPM-T), Pain Pressure Threshold Task (PPT-T), ReyAuditory-Verbal Learning Test (RAVLT), Controlled Oral Word Association Test (COWAT) and blood collection for serum levels of BDNF and S100B. For the main outcome, comparison between variables during time will be made through linear regression, with an adjustment for baseline levels and possible confounders.

Read the detailed description

Recruitment: The study will be held in a clinical center at Novo Hamburgo (RS) -Brazil.Data collection will begin in December 2021, and it will end when sample size is achieved. A targeted approach will be used: recruiting referrals from clinics in the region of the study setting, along with patients from the clinical center where the trial will be conducted. Besides that, posters will be placed in common areas and posted on social media. Inclusion Criteria: women from 30 to 65 years old; FM diagnosis according to ACR criteria (2016); pain on VAS equal to or higher than 6 in the last 3 months; chronic stable treatment over the past 3 months.

Exclusion Criteria: pregnancy or lack of contraceptive use; history of alcohol or drug abuse in the last 6 months, neurological disorders, cardiac arrhythmia; use of drugs that change vascular response; history of head trauma, mild or severe, neurosurgery; decompensated systemic diseases; current diagnosis or history of cancer.

tPCSThe procedure will begin with placement of bilateral circular electrodes in the inferior ear lobe (ECG position A1) fixed by an ear clip. The electrode's radius will be approximately 0.785cm2. Current has a peak pulse amplitude of 2mA, with a frequency range from 6 to 10 Hz. A battery-powered current stimulator will be used. This device provides stimulation through biphasic and alternating square wave pulse, with random pulse width range from 1 to 20 ms. tPCS sessions will last 20 minutes plus 5 minutes for setting up, meanwhile when questionnaires and tests are applied, sessions can last 1 to 2 hours. Sessions will be made in a 1+4 way, in which outcomes will be evaluated before and after the first session and after the last session. Studies display evidence of clinical improvement after 5 sessions of transcranial electrical stimulation in FM. A standardized questionnaire will be performed in order to observe adverse effects immediately after the intervention.Sham tPCSThe current will only be applied for the first 30 seconds. Patients may notice the same sensation of initial stimulation but will not receive the current for the remaining time. Analogue to tPCS, 5 sessions will be performed.

Conditions
Fibromyalgia
Being tested
Transcranial Pulsed Current Stimulation
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Pulsed Current StimulationDevice

    Current has a peak pulse amplitude of 2mA, with a frequency range from 6 to 10 Hz. A battery-powered current stimulator will be used. This device provides stimulation through biphasic and alternating square wave pulse, with random pulse width range from 1 to 20 ms

Study groups in NCT05321693
Study groupRoleWhat they receive
Active tPCSActive comparatorNot described
Receives: Device: Transcranial Pulsed Current Stimulation
Sham tPCSSham comparatorThe currentwill only be applied forthe first 30 seconds. Patients may notice the same sensation of initial stimulation butwill not receive the current for the remaining time.
Receives: Device: Transcranial Pulsed Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain on Visual Analogue Scale (VAS)

    a continuous scale from 0-100mm, considering 60mm as the minimum for chronic pain

    Measured: Change from day 5 to baseline

Secondary outcomes (8)

  1. Quality of Sleep

    Pittsburgh Sleep Quality Index (PSQI) - from 0 to 21. The higher the worse

    Measured: Change from day 5 to baseline

  2. Impact of Fibromyalgia

    Fibromyalgia Impact Questionnaire (FIQ), subdivided into overall impact, symptoms and function. From 0 to 100. The higher the worse

    Measured: Change from day 5 to baseline

  3. Pain Catastrophizing

    Pain Catastrophizing Scale (PCS), subdivided into magnification, rumination, and hopelessness. From 0 to 52. The higher the worse

    Measured: Change from day 5 to baseline

  4. Profile of Pain

    Profile of Chronic Pain (PCP), subdivided into pain intensity and frequency (1-4), the impact of pain in activities (5-10), and impact of pain in emotions (11-15). The higher the worse

    Measured: Change from day 5 to baseline

  5. Descending Inhibitory System

    Conditioned Pain Modulation task: evaluate the descending inhibitory system of pain, measured by the difference of pain (VAS) between two painful stimuli. From -6 to 4. As far from 0 the worse

    Measured: Change from day 5 to baseline

  6. Pain Pressure Threshold

    anelectronic algometer will be placed in the forearm, patient will report first pain sensation and maximum pain. Starts in 0. The closer to zero the worst.

    Measured: Change from day 5 to baseline

  7. Serum levels of BDNF, S100B, and estradiol

    ELISA Technique. Starts in 0

    Measured: Change from day 5 to baseline

  8. Cognitive Impairment

    Controlled Oral Word Association Test (COWAT) for cognitive evaluation. Starts in 0. The higher the better

    Measured: Change from day 5 to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start10 Dec 2021
  3. Primary completion10 Dec 2021
  4. Study completion10 Dec 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-center, randomized, double-blinded, parallel-group, sham-controlled trial to evaluate the superiority of tPCS in pain reduction in women with FM
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321693
Sponsor's protocol ID
49683221.2.0000.5307
Status last verified
Apr 2022
First submitted
25 Mar 2022
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcranial Pulsed Current Stimulation in people with Fibromyalgia, run by Centro Universitario La Salle at 2 sites in Brazil.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on Visual Analogue Scale (VAS) (time frame: Change from day 5 to baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05321693.

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 11 Apr 2022.

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