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Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia

Primary Purpose

Fibromyalgia, Food Addiction

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sham transcranial direct current stimulation (tDCS)
Active transcranial direct current stimulation (tDCS)
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring polymorphism Taq1A, tDCS, dopamine, eating behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clinicas de Porto Alegre
  • Wolnei CaumoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

sham tDCS

active tDCS

Arm Description

For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session.

The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively.

Outcomes

Primary Outcome Measures

Three Factor Eating Questionnaire 21
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 Outcome Measures

weight
measured by scale
waist circumference.
measured by measuring tape
State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)
- FCQ-T consists of 39 statements and was developed to access food cravings aspects over time and in various situations, considering them as a (usual) trait behavior of the respondent. Higher scores in this questionnaire are related to a more exaggerated eating. - FCQ-S is composed of 15 statements and is a tool sensitive to changes in contextual, psychological and physiological states in response to specific situations (such as stressful events or food deprivation), considering the food craving as a (sporadic) state behavior of the respondent. Higher scores in this questionnaire are associated with greater food deprivation, negative eating-related experiences and a greater susceptibility to triggers that lead to eating. Totals of both tools for the full subscales and their dimensions are calculated by adding the corresponding scores of each statement.
Hunger and satiety diary
Hunger and satiety measured by the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of hunger or appetite and 100 mm hunger or maximum appetite. Patients should report hunger, hunger or satiety for most of the last 24 hours.
Appetite Diary
Appetite measured by means of the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of appetite and 100 mm or maximum appetite. Patients should report nonspecific appetite for sweet or salty most of the last 24 hours.

Full Information

First Posted
October 31, 2019
Last Updated
January 9, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04192058
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Food Addiction
Keywords
polymorphism Taq1A, tDCS, dopamine, eating behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session.
Arm Title
active tDCS
Arm Type
Experimental
Arm Description
The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively.
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation (tDCS)
Intervention Description
For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session.
Intervention Type
Device
Intervention Name(s)
Active transcranial direct current stimulation (tDCS)
Intervention Description
Transcranial direct current stimulation (tDCS) it is a therapeutic method that modulates membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min.
Primary Outcome Measure Information:
Title
Three Factor Eating Questionnaire 21
Description
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.
Time Frame
6 mouths
Secondary Outcome Measure Information:
Title
weight
Description
measured by scale
Time Frame
up to 2 weeks
Title
waist circumference.
Description
measured by measuring tape
Time Frame
up to 2 weeks
Title
State and Trait Food-Cravings Questionnaires (FCQ-s e FCQ-t)
Description
- FCQ-T consists of 39 statements and was developed to access food cravings aspects over time and in various situations, considering them as a (usual) trait behavior of the respondent. Higher scores in this questionnaire are related to a more exaggerated eating. - FCQ-S is composed of 15 statements and is a tool sensitive to changes in contextual, psychological and physiological states in response to specific situations (such as stressful events or food deprivation), considering the food craving as a (sporadic) state behavior of the respondent. Higher scores in this questionnaire are associated with greater food deprivation, negative eating-related experiences and a greater susceptibility to triggers that lead to eating. Totals of both tools for the full subscales and their dimensions are calculated by adding the corresponding scores of each statement.
Time Frame
6 mouths
Title
Hunger and satiety diary
Description
Hunger and satiety measured by the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of hunger or appetite and 100 mm hunger or maximum appetite. Patients should report hunger, hunger or satiety for most of the last 24 hours.
Time Frame
up to 24 hours
Title
Appetite Diary
Description
Appetite measured by means of the 100 mm Analog-Visual Scale (VAS), whose zero corresponds to the absence of appetite and 100 mm or maximum appetite. Patients should report nonspecific appetite for sweet or salty most of the last 24 hours.
Time Frame
up to 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, Md PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.450-120
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Wolnei Caumo
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo
Phone
55 51 33598001
Email
wolneicaumo@hcpa.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia

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