Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia

NCT05321693 | Unknown Phase 2 DMC

• 1 other identifier: 49683221.2.0000.5307
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Pain on Visual Analogue Scale (VAS)

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

  Change from day 5 to baseline

Secondary Outcomes (8)

• Quality of Sleep

  Change from day 5 to baseline

• Impact of Fibromyalgia

  Change from day 5 to baseline

• Pain Catastrophizing

  Change from day 5 to baseline

• Profile of Pain

  Change from day 5 to baseline

• Descending Inhibitory System

  Change from day 5 to baseline

Study Arms (2)

Active tPCS

ACTIVE COMPARATOR

Device: Transcranial Pulsed Current Stimulation

Sham tPCS

SHAM COMPARATOR

The 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.

Device: Transcranial Pulsed Current Stimulation

Interventions

Transcranial Pulsed Current Stimulation DEVICE

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

Active tPCS; Sham tPCS

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of neurosurgery;
• Decompensated systemic diseases;
• Current diagnosis or history of cancer

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (2)

Universidade La Salle

Canoas, Rio Grande do Sul, 92010-000, Brazil

RECRUITING

Instituto de Neuromodulação e Reabilitação Avançada

Novo Hamburgo, Rio Grande do Sul, 93520575, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Based on the nature of the intervention, participants and physicians (health care providers/investigators) shall be blinded. Only one investigator will have access to the randomization list and will program the stimulation according to the list. The device comes programmed to perform the task input by the investigator, which will be trained by previous enrollment to the study onhow to perform the intervention. Sham stimulation occurs only for the initial 30seconds, afterwhich the patient should feelthat the body adjusts to the stimuli.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Model Details: 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

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 11, 2022
• Study Start: December 10, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)