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

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ClinicalTrials.gov Identifier: NCT02180984
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Angélica de Medeiros Claudino, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE July 3, 2014
Last Update Posted Date August 9, 2018
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2014)
Change in the number of binge eating episodes and frequency. [ Time Frame: Average of 2 months ]
Weekly binge eating episodes frequency will be assessed by the medical doctor. 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.
Change History Complete list of historical versions of study NCT02180984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2014)
  • Stroop test scores baseline difference. [ Time Frame: Baseline ]
    Difference between groups of baseline Stroop test scores.
  • 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).
  • 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).
  • 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).
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED
Official Title  ICMJE The Effects of Repetitive Transcranial Magnetic Stimulation in Obese Females With Binge Eating Disorder: a Protocol for a Double-blinded, Randomized, Sham-controlled Trial.
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Eating
  • Obesity
Intervention  ICMJE Device: TMS
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
Study Arms  ICMJE
  • Active Comparator: BED randomized to rTMS

    30 obese individuals currently diagnosed with BED and meeting criteria for the study will be randomized to active rTMS treatment.

    Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method).

    Proposed schedule of treatment:

    20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. For the real treatment condition, stimulation will target the left DLPFC at 110% of the resting motor threshold. Each session of 10 Hz stimulation will apply 1000 pulses to the left hemisphere, with a duty cycle of 5s on and 55s off, for a total stimulation time of 20 min.

    Intervention: Device: TMS
  • Sham Comparator: Sham BED TMS

    30 obese individuals currently diagnosed with BED will be randomized to receive sham TMS treatment. Blinded to participants and study staff, except to the doctor applying the TMS treatment.

    Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method).

    Proposed schedule of treatment:

    20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. Sham treatment condition, will follow the same protocol however no real TMS will be delivered.

    Intervention: Device: TMS
  • No Intervention: Control (obese non BED)
    15 controls, obese but without a current or past diagnosis of BED will complete the baseline measurements only.
  • No Intervention: Controls (normal weight)
    15 controls, normal weight and without a current or past diagnosis of BED will complete baseline measures only.
Publications * Maranhão MF, Estella NM, Cury ME, Amigo VL, Picasso CM, Berberian A, Campbell I, Schmidt U, Claudino AM. The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. BMC Psychiatry. 2015 Aug 12;15:194. doi: 10.1186/s12888-015-0569-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nara Mendes Estella, Psychology + 55 (11) 97497 5978 naramendes@alumni.harvard.edu
Contact: Mara Maranhão, Psychiatrist + 55 (11) 99241 74 73 mara.proata@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02180984
Other Study ID Numbers  ICMJE 26164614.7.0000.5505
26164614.7.0000.5505 ( Other Identifier: CEP UNIFESP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angélica de Medeiros Claudino, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angélica M Claudino, MD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP