Effects of Combined Treatment With tDCS and Cognitive Training in Patients With Fibromyalgia

NCT02880917 | Completed

• 1 other identifier: 140369
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain represents an important health problem responsible for decreases in quality of life, and is associated with great negative impact in society and economy. In many cases, its treatment does not reach therapeutic success causing health professionals and patients dissatisfaction. Chronic pain is also associated with somatization, hopelessness and catastrophizing thinking. These information processing includes sensorial, emotional and cognitive-appraisal thinking, which manifests the working of neural networks at cortical and sub-cortical levels. Attention and memory are a central aspect in the processing of pain modulation. Like in addictions (e.g. smoking, alcohol), chronic pain may debut with displacement in the focus of attention and alterations in the sensorial processing in the incentive-motivation tests. Considering that other studies have indicated that experimental and clinical pain is capable of modulating cognitive activities such as attention,memory and expectation, in this study the investigators will test whether cognitive training, tDCS, or the combination of both interventions decrease cognitive deficits associated with Fibromyalgia

Conditions

Fibromyalgia

Keywords

Attention; Memory (short and long-term); Conflict monitoring tasks; Verbal fluency

Outcome Measures

Primary Outcomes (1)

• Evaluate whether the tdcs associated with cognitive training technique or the combination of both interventions decrease memory deficits associated with Fibromyalgia.

  I will use the rey auditory-verbal learning test(RAVLT) to evaluate the memory functions of patients with fibromyalgia, before and after treatment with TDCS and cognitive training.

  8 days

Secondary Outcomes (3)

• Pain

  8 days

• Scale Functional capacity--(Using The Brazilian Portuguese version of the Profile of Chronic Pain.)

  2 days

• Test -Conditional pain modulation (CPM)

  2 days-pre and pos application tDCS

Other Outcomes (11)

• Maximal Heat Pain Tolerance

  2 days

• Pain catastrophizing thoughts

  2 days

• Serum levels of Brain Derived Neurotrophic Factor (BDNF)

  2 days

Study Arms (2)

Cognitive training + tDCs-Active

ACTIVE COMPARATOR

tDCs active left dorsolateral prefrontal cortex (2mA,20 min) and Cognitive training (20min) at the same time.

Device: tDCS-Active; Other: Cognitive training

Cognitive training+ tDCs-Sham

SHAM COMPARATOR

tDCs Sham dorsolateral prefrontal cortex ((2mA,20 min) and Cognitive training (20min) at the same time.

Device: tDCS-Sham; Other: Cognitive training

Interventions

tDCS-Sham DEVICE

Sham tDCS will involve an identical electrode montage, with stimulation ceasing after a 30-second ramp-up period to provide equivalent scalp sensation.

Cognitive training+ tDCs-Sham

tDCS-Active DEVICE

tDCS was delivered using the anode electrode positioned over the left dorsolateral prefrontal cortex (DLPFE) and the cathode electrode at supra orbital right region. The electrodes were placed into a 25-35 cm2 square sponge immersed in saline solution for better current conductivity. Current density used was 2 mA and electrodes attached to the scalp were sustained by rubber band.

Cognitive training + tDCs-Active

Cognitive training OTHER

. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.

Cognitive training + tDCs-Active; Cognitive training+ tDCs-Sham

Eligibility Criteria

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

You may qualify if:

• Female patients
• literate
• right-handed
• to 65 years of age
• who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

You may not qualify if:

• Pregnant women
• Contraindications to tDCS
• Metal implant in the brain
• History of alcohol or drug abuse in the last six months
• History of neurological disorders
• Unexplained fainting
• Self-reports of head injury or momentary loss of awareness
• Neurosurgery.
• Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Wolnei Caumo, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 26, 2016
• Study Start: November 1, 2015
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

BR (1)