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

NCT ID: NCT02180984

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-12-31

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.

Conditions

Binge Eating; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TMS

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: 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.

Control (obese non BED)

15 controls, obese but without a current or past diagnosis of BED will complete the baseline measurements only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Controls (normal weight)

15 controls, normal weight and without a current or past diagnosis of BED will complete baseline measures only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Repetitive Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation; rTMS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

ANGELICA CLAUDINO

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angélica M Claudino, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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

São Paulo, , Brazil

Countries

Brazil

References

Maranhao 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.

Reference Type: BACKGROUND

PMID: 26265452 (View on PubMed)

Other Identifiers

26164614.7.0000.5505

Identifier Type: OTHER

Identifier Source: secondary_id

26164614.7.0000.5505

Identifier Type: -

Identifier Source: org_study_id