Clinical trial NCT04192058: Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia
Official title: Effect of Transcranial Direct-current Stimulation in Homeostastic and Hedonistic Mechanisms of Eating Behavior in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Food Addiction
Keywords: polymorphism Taq1A
tDCS
dopamine
eating behavior
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Right-handers who can read and write,
* Confirmed diagnosis of FM
* Pain score of six or more on the Numerical Pain Scale (SPN 0-10) on most days of the last 3 months.

Exclusion criteria:

Living outside the Greater Porto Alegre area and pregnancy. Contraindications to EMT and ETCC: 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 disorders; hx 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. Weight loss use and bariatric surgery.

Primary outcomes:
measure: Three Factor Eating Questionnaire 21
timeFrame: 6 mouths
Secondary outcomes:
measure: weight
timeFrame: up to 2 weeks
measure: waist circumference.
timeFrame: up to 2 weeks
measure: State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)
timeFrame: 6 mouths
measure: Hunger and satiety diary
timeFrame: up to 24 hours
measure: Appetite Diary
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Wolnei Caumo
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Wolnei Caumo, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: