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Completed

NCT Number: NCT02180984

The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED

The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating disorder (BED) is a new category in DSM-5 highly associated with higher body mass index (BMI). The neural mechanisms that underlie BE are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several novel studies began to assess the potential benefits of brain stimulation in reducing craving and associated addictive behaviors with promising results. Previous findings testing a one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating disorders reported reduction of food craving and BE, providing evidence to support a broader and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain imaging studies contributes to the understanding of psychiatric disorders and underlying mechanisms being target by the rTMS intervention.

Objectives: The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.

Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.

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Key information

Conditions

Binge Eating Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Paulo (Federal University of Sao Paulo) (UNIFESP)

São Paulo, 04021-001, Brazil

About this study

The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.

Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 55 years old
  • Right handed
  • Females
  • BED diagnosis (EDE 16.0 - BED module) according to the DSM-5 criteria
  • BMI ≥ 35kg/m2 and body weight ≤ 150kg
  • Ability to write, read, and understand all elements of the study
  • Safety laboratory blood work (fasting glucose, fasting glucose/insulin ratio, CBC, and TSH) within normal range
  • Informed consent signed.

Exclusion criteria

  • Past history of head or eye injury or epilepsy
  • Body metallic implants, pacemaker, claustrophobia and any other contraindication to fMRI or rTMS;
  • Current use of psychotropic drugs (except for antidepressants on a stable dose for at least one month)
  • Current use of any anti-obesity drug (three months washout period for any other medication)
  • Pregnancy or breastfeeding
  • Diabetes Mellitus diagnosis
  • Major psychiatric disorder requiring immediate treatment
  • Substance dependence (SCID-I/P module for substance abuse and/or dependence applied for those who disclose substance use at checklist, following the DSM-5 criteria)
  • Individuals currently receiving any psychological therapy for their eating disorder
  • Cushing's and Turner's syndrome.

Treatment and study plan

TMS

Device

Transcranial Magnetic Stimulation has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex.

Other names: Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, rTMS

Primary outcomes

  1. Change in the number of binge eating episodes and craving.

    Time frame: Average of 2 months

    Weekly binge eating episodes frequency will be assessed by the medical doctor. The primary outcomes of this study are: (1) the change in the number of BE episodes before and after study treatment (number of BE episodes at baseline subtracted from the number of BE episodes at the end of treatment), as measured by participants recording of binge episodes in the food diary during the previous 15 days to the baseline visit (first rTMS session,T.3) to the end of treatment visit (T.23); (2) the change in "urge to eat" (craving) as measured in a 10 cm VAS (from T3 to T22).

Secondary outcomes

  1. Change of food craving questionnaires (state and trait) scores

    Time frame: Average of 2 months (baseline and end of treatment)

    Food craving questionnaires scores will be analyzes at baseline and at the end of the treatment (approximately 2 months). Final scores for each of the participants will be subtracted from the baseline scores.

  2. Change in Body Weight

    Time frame: Average of 2 months

    Reduction of baseline body weight (kg) at the end of the treatment (average of 2 months). The final weight will be subtracted from the baseline weight for each of the patients.

  3. Binge eating episodes maintenance

    Time frame: 8 weeks follow up (after end of treatment)

    Weekly binge eating episodes frequency will be recorded by participants. Participants will asked to record date, time and description of binge eating episodes. The total number of episodes and frequency distribution for each of the groups will be analyzed.

  4. Change of visual analogue scale scores

    Time frame: Average of 2 months (baseline and end of treatment)

    visual analogue scale scores will be analyzes at baseline and at the end of the treatment (approximately 2 months). Final scores for each of the participants will be subtracted from the baseline scores.

Other outcomes

  1. Stroop test scores baseline difference.

    Time frame: Baseline

    Difference between groups of baseline Stroop test scores.

  2. Assessment of adverse events and tolerability

    Time frame: Average of 2 months

    During the study participants will be asked if they are experiencing any of the expected adverse events or adverse events that are not expected. Number of expected and not expected adverse events will be recorded. Number of participants experiencing adverse events will be recorded. In addition participants will complete the tolerability scale at the end of each of TMS session and group mean score will be analyzed at the end of the treatment (average of 2 months).

  3. Change in hormone levels

    Time frame: Average of 2 months

    Assessment of hormones (ghrelin (pg/mL), leptin (ng/mL), Peptide YY (pg/mL) and estrogen (pg/mL)), inflammatory biomarkers (PCR (mg/L), TNF-alpha(pg/mL), IL-6 (pg/mL), IL-10 (pg/mL)), anti-inflammatory biomarkers (adiponectin (µg/mL) and IL-2 (pg/mL)) and BDNF. Group mean baseline levels compared to group means at the end of treatment (average of 2 months).

  4. Stroop test and fMRI

    Time frame: Baseline

    Stroop test performance during the fMRI will be analyzed between groups. Better inhibitory response and greater activation in response inhibition regions, such as DLPFC, will be analyzed to assess differences between groups (control and randomized).

  5. Stroop test performance long term

    Time frame: Approximately 2 months

    Stroop test performance during the fMRI will be analyzed between groups. Better inhibitory response and greater activation in response inhibition regions, such as DLPFC, will be analyzed to assess differences between groups (placebo and sham).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

The Effects of Repetitive Transcranial Magnetic Stimulation in Obese Females With Binge Eating Disorder: a Protocol for a Double-blinded, Randomized, Sham-controlled Trial.

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 3, 2014
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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