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Clinical Trials/NCT04192058
NCT04192058
Unknown
Not Applicable

Effect of Transcranial Direct-current Stimulation in Homeostastic and Hedonistic Mechanisms of Eating Behavior in Women With Fibromyalgia

Hospital de Clinicas de Porto Alegre2 sites in 1 country60 target enrollmentSeptember 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
60
Locations
2
Primary Endpoint
Three Factor Eating Questionnaire 21
Last Updated
6 years ago

Overview

Brief Summary

Introduction: Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. A high prevalence of overweight in patients with fibromyalgia is observed, about 80% according to current data, which affects the course and prognosis of the disease, besides overburdening health costs and further compromising quality of life. life of these patients. Evidence shows possible pathophysiological pathways shared by these two pathologies, as well as aspects related to food behavior. It is known that dopaminergic neurotransmission is altered in both, suggesting an increase in the sensitivity or density of D2 dopamine receptors. Non-pharmacological options for pain management and dysfunctional eating behavior include the important contribution of neuromodulatory techniques of non-invasive cerebral stimulation, such as transcranial direct current stimulation (tDCS), which aims to increase resisting hyperpalatable foods and reducing caloric intake. Objectives: To evaluate the association between dopamine receptor-2 (DRD2) Taq1A allele A1 polymorphism (rs1800497) and to observe the possible effect of tDCS on the dorsolateral prefrontal cortex (DLPFC) on homeostatic and hedonistic aspects of eating behavior in women with FM. Methods: A randomized, double blind, parallel group, controlled trial with simulated treatment will be performed. Will be included in the study women literate, right-handed, with confirmed diagnosis of FM. The evaluation will be done through questionnaires on pain and eating behavior, anthropometric evaluation and biochemical measurements. The intervention will take place through active or simulated home for 4 weeks. Perspectives: To evaluate dysfunctional neuroplastic changes in eating behavior and biological markers and also to serve as a basis for future effective treatment strategies through neuromodulation and nutritional counseling.

Detailed Description

A randomized, double-blind, parallel-group controlled trial with sham treatment will be conducted in fibromyalgia patients to assess aspects of eating behavior.

Registry
clinicaltrials.gov
Start Date
September 15, 2019
End Date
December 15, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Three Factor Eating Questionnaire 21

Time Frame: 6 mouths

TFE-Q was developed by Stunkard and Messic (1985) to access three dimensions of human eating behavior: Cognitive Restriction (CR), Eating Disorder (AD) and Emotional Eating (AE). Originally made up of 51 items and reduced in the TFEQ-18, TFEQ-18, TFEQ-21 versions. We will use the TFEQ-21. The average obtained from the sum of the questions for each domain was converted to a scale ranging from 0 to 100. Evaluates dysfunctional eating behavior. Cognitive restriction: limitation of food intake for weight control; Uncontrolled Food: Tendency to lose control over eating from hunger or when exposed to external environments, even in the absence of physiological hunger; Emotional Eating: Susceptible to eating in response to emotional stress or negative mood.

Secondary Outcomes

  • waist circumference.(up to 2 weeks)
  • Hunger and satiety diary(up to 24 hours)
  • Appetite Diary(up to 24 hours)
  • State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)(6 mouths)
  • weight(up to 2 weeks)

Study Sites (2)

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