Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder

September 2, 2019 updated by: Katarína Jaššová, Charles University, Czech Republic

Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder. A Double Blind Placebo Controlled Study

Hypothesis: High-frequency rTMS can significantly reduce craving for food in patients with BED just after the stimulation and also over the one month observation period.

Method: The study was designed as a randomized double blind and placebo controlled one. The active group was stimulated by high-frequency rTMS, with the following stimulation parameters: frequency 10 Hz, 1500 pulses, 107 s inter-train, 100% minimal motor threshold and 10 stimulation session. The control group was stimulated by a sham rTMS coil. The FCQ-S and the FCQ-T questionnaires were used to evaluate the food craving.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study was realized at Department of Psychiatry First Faculty of Medicine Charles University in Prague and General University Hospital in Prague during 2013 - 2018. The study was approved by the Ethics committee General University Hospital in Prague by a decision dated 23.1.2014, number 1867/13 S-IV (individual research). The study was registered on clinicaltrials.gov.

Two psychiatrists examined each patient who signed up for the study, in order to set the diagnoses. The DSM-5 diagnostic criteria were used for the purpose of the study. The exclusion criteria were mainly based upon contraindications for rTMS such as: a history of epileptic seizure paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump. Also, patients who were not able to complete 10 sessions of rTMS were excluded for non-compliance. Inclusion criteria were: having BED and being over the age of 18. The study did not account for the hemispherical laterality.

After signing an informed consent form, subjects were included into the study and randomly divided into two groups: one group stimulated by a real rTMS coil (group A - active), and the second (control group), stimulated by a sham rTMS coil (group P - placebo).

Patients were also offered to participate in cognitive behavioral group therapy (CBT) simultaneously with the rTMS treatment. However, the attendance in the CBT was voluntary, and it was not a condition for inclusion into the study.

The study was conceived as randomized double blind placebo controlled clinical study. The randomization was performed by statistics independent of study. The investigators group achieved the study´s double blind characteristics by dividing the roles of the researchers. One author provided the examinations of the patients, CBT, data collection and evaluations of the questionnaires, while a second author administered the stimulations. The control group was "blind" thanks to the use of the sham coil.

Collection of data and statistical analysis Subjects were asked to fill out the set of questionnaires consisting of the EDE-Q (Eating Disorder Examination - Questionnaire), as well as the FCQ-S, and the FCQ-T before the first stimulation session. The EDE-Q served to collect demographfic data, and to evaluate the severity of the disorder. On the day of the last stimulation, and one month after the last stimulation, subjects filled out the FCQ-S and the FCQ-T again.

Statistical package R, version 3.4.2 was used for the statistical processing of the data. The two-sample t-test method was used to compare the differences in cravings between subjects stimulated by the real and sham coils in all situations: before stimulation, directly after the last stimulation, and one month after the last stimulation. The paired t-test method was used to evaluate the changes of craving over time, meaning the difference in craving before the stimulation and on the last day of stimulation, and difference in craving on the last day of stimulation and one month after the last stimulation.

Parameters of stimulation A MAGSTIM Super Rapid 2 device with eight flat shaped coil was used to provide the rTMS. The control group was stimulated by a sham coil with similar side effects regarding sound and a pain perception on the scalp. The left DLPFC was chosen as the stimulation target. The coil placement for the DLPFC stimulation was 5 cm anterior in the same parasagital line from the place of maximum musculus abductor pollicis brevis response. The stimulation site was outlined on a cap, which was repositioned during each rTMS session.

The number of sessions was set on 10. Each stimulation session consisted of 15 trains of 10 s and 107 s intertrain, at a frequency of 10 Hz. That meant 1500 pulses applied during one session taking cca 20 minutes. The intensity of stimulation was 100% of minimal motor threshold (MMT). MMT was identified as the minimum magnetic field strength required to produce a motoric response of right thenar muscle, which was determined by visual control and controlled by EMG measurement. Stimulations were realized throughout a two week period, excepting weekends.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • having binge eating disorder
  • being over the age of 18

Exclusion Criteria:

  • contraindications for rTMS such as: a history of epileptic seizur paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump
  • non-compliance - inability to complet 10 sessions of stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: stimulated group
The group stimulated by real coil of rTMS.
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
SHAM_COMPARATOR: controle group
The group stimulated by sham coil of rTMS.
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of craving
Time Frame: one month
For evaluation of craving the Food Craving Questionnaire-State (FCQ-S) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-State (FCQ-S) consisted of 15 questions, which are focused on the craving being dependent on the actual psychological conditions of the subject. The degree of craving can range from 0 to 65 points.
one month
The degree of craving
Time Frame: one month
For evaluation of craving the Food Craving Questionnaire-Trait (FCQ-t) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-Trait (FCQ-T) consisted of 39 questions focused on the craving as a stable property over time. The degree of craving can range from 0 to 195 points.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2014

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (ACTUAL)

September 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CharlesUniversityPragueCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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