Long Term Home Based tDCS in Fibromyalgia

NCT03843203 | Unknown DMC

• 1 other identifier: 2017-0330
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia(FM) is a widespread musculoskeletal pain syndrome characterized by fatigue, sleep disorders, cognitive impairment, depressive symptoms and neuro-vegetative symptoms. It is a multivariable and complex neurobiological process. FM worldwide prevalence according to American College of Rheumatology (ACR) 2010 diagnostic criteria is estimated under 5,4%. In USA the burden caused by FM is estimated at 29 billions every year, due to assistance, health care costs and retirement to loss of productivity. It is known that conventional pharmacological approaches present poor therapeutic response in more than 50% of these patients. It is conceivable that this limited results, at least in part, due to the lack of a complete elucidation of its pathophysiology. Our hypothesis is that tDCS has a superior effect on clinical outcomes, functional capacity, cortical excitability, and psycho-affective functions compared to simulated treatment. In order to respond to the objectives of this study, a randomized, parallel-blinded clinical trial will be conducted. FM patients will be randomized to receive tDCS with anodic pole on the primary motor cortex and the cathode pole on the contralateral prefrontal cortex.

Conditions

Fibromyalgia; Transcranial Direct Current Stimulation

Keywords

Pain; Brain derived neurotrophic factor; functional capacity

Outcome Measures

Primary Outcomes (2)

• Change in pain level - first phase

  Change from before and after the First phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)

  1 month

• Change in functional capacity - first phase

  Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)

  1 month

Secondary Outcomes (6)

• Change in pain level - second phase

  3 months

• Change in functional capacity - second phase

  3 months

• Change in Function of modulatory descending system

  1 month

• Change in Function of corticospinal pathway

  1 month

• Change in levels of Brain derived neurotrophic factor - BDNF

  1 month

Study Arms (3)

s-tDCS

SHAM COMPARATOR

\- Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS sham treatment. The patients will receive sham tDCS treatment over primary motor cortex. According to 10-20 EEG system, anode will be placed at left C3 and cathode at o contralateral F3. In sham stimulation the device only release flow current, in the first 30 s of session and in the remaining 30s in the end of the session, during 20 minutes.

Device: Transcranial Direct Current Stimulation - tDCS

M1 a-tDCS

ACTIVE COMPARATOR

* Intervention: 'Transcranial Direct Current Stimulation - tDCS * The patients will receive tDCS active treatment over primary motor cortex. * According to 10-20 EEG system, anode will be placed at left C3 and cathode at contralateral supraorbital Fp2. * Active stimulation uses a 2 milliamperes current during 20 minutes.

Device: Transcranial Direct Current Stimulation - tDCS

DLPFC a-tDCS

ACTIVE COMPARATOR

* Intervention: 'Transcranial Direct Current Stimulation - tDCS * The patients will receive tDCS active treatment over dorsolateral prefrontal cortex. * According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4. * Active stimulation uses a 2 milliamperes current during 20 minutes.

Device: Transcranial Direct Current Stimulation - tDCS

Interventions

Transcranial Direct Current Stimulation - tDCS DEVICE

\- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it

DLPFC a-tDCS; M1 a-tDCS; s-tDCS

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, who are able to read and write, with confirmed diagnosis of FM according to the criteria of the American College of Rheumatology (2010-2016).
• Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months.

You may not qualify if:

• Reside outside the Greater Porto Alegre area
• Pregnancy
• Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant;
• History of alcohol or drug abuse in the last 6 months; neurological diseases; history of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

RECRUITING

Related Publications (8)

• Clauw DJ, Arnold LM, McCarberg BH; FibroCollaborative. The science of fibromyalgia. Mayo Clin Proc. 2011 Sep;86(9):907-11. doi: 10.4065/mcp.2011.0206.

  PMID: 21878603 BACKGROUND

• Keeser D, Meindl T, Bor J, Palm U, Pogarell O, Mulert C, Brunelin J, Moller HJ, Reiser M, Padberg F. Prefrontal transcranial direct current stimulation changes connectivity of resting-state networks during fMRI. J Neurosci. 2011 Oct 26;31(43):15284-93. doi: 10.1523/JNEUROSCI.0542-11.2011.

  PMID: 22031874 BACKGROUND

• Silva AF, Zortea M, Carvalho S, Leite J, Torres IL, Fregni F, Caumo W. Anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex modulates attention and pain in fibromyalgia: randomized clinical trial. Sci Rep. 2017 Mar 9;7(1):135. doi: 10.1038/s41598-017-00185-w.

  PMID: 28273933 BACKGROUND

• Zanette SA, Dussan-Sarria JA, Souza A, Deitos A, Torres IL, Caumo W. Higher serum S100B and BDNF levels are correlated with a lower pressure-pain threshold in fibromyalgia. Mol Pain. 2014 Jul 8;10:46. doi: 10.1186/1744-8069-10-46.

  PMID: 25005881 BACKGROUND

• Lopes Alves R, Zortea M, Vicuna Serrano P, Laranjeira VDS, Franceschini Tocchetto B, Ramalho L, Fernanda da Silveira Alves C, Brugnera Tomedi R, Pereira de Almeida R, Machado Bruck S, Medeiros L, R S Sanches P, P Silva D Jr, Torres ILS, Fregni F, Caumo W. Modulation of neural networks and symptom correlated in fibromyalgia: A randomized double-blind multi-group explanatory clinical trial of home-based transcranial direct current stimulation. PLoS One. 2024 Nov 13;19(11):e0288830. doi: 10.1371/journal.pone.0288830. eCollection 2024.

  PMID: 39536019 DERIVED

• Caumo W, Lopes Ramos R, Vicuna Serrano P, da Silveira Alves CF, Medeiros L, Ramalho L, Tomeddi R, Bruck S, Boher L, Sanches PRS, Silva DP Jr, Ls Torres I, Fregni F. Efficacy of Home-Based Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex in the Disability Due to Pain in Fibromyalgia: A Factorial Sham-Randomized Clinical Study. J Pain. 2024 Feb;25(2):376-392. doi: 10.1016/j.jpain.2023.09.001. Epub 2023 Sep 7.

  PMID: 37689323 DERIVED

• Serrano PV, Zortea M, Alves RL, Beltran G, Bavaresco C, Ramalho L, Alves CFDS, Medeiros L, Sanches PRS, Silva DP Jr, Lucena da Silva Torres I, Fregni F, Caumo W. The effect of home-based transcranial direct current stimulation in cognitive performance in fibromyalgia: A randomized, double-blind sham-controlled trial. Front Hum Neurosci. 2022 Nov 24;16:992742. doi: 10.3389/fnhum.2022.992742. eCollection 2022.

  PMID: 36504629 DERIVED

• Caumo W, Alves RL, Vicuna P, Alves CFDS, Ramalho L, Sanches PRS, Silva DP, da Silva Torres IL, Fregni F. Impact of Bifrontal Home-Based Transcranial Direct Current Stimulation in Pain Catastrophizing and Disability due to Pain in Fibromyalgia: A Randomized, Double-Blind Sham-Controlled Study. J Pain. 2022 Apr;23(4):641-656. doi: 10.1016/j.jpain.2021.11.002. Epub 2021 Nov 13.

  PMID: 34785366 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Wolnei Caumo, PhD

CONTACT

+5551 3359 8083; wcaumo@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher will receive equipment already programmed by a research assistant, so the researcher who will deliver the tDCS to perform stimulation will not know the programed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent evaluators who will not participate in the consultations where guidance on the use of tDCS will be provided will be trained to make outcome assessments in follow-up. Patients will not be aware of the type of intervention received, since the sham condition produces a stimulus, but no expected effects. In order to study the level of the blinding, at each moment of evaluation, the patient will be asked about the type of intervention that he / she believes to have received (active or simulated), and about the degree of safety in the response, using a standardized questionnaire. The blinding will be evaluated at the end of each treatment week by means of a standardized instrument.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D, PhD.

Model Details: Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 18, 2019
• Study Start: June 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)