Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder

NCT04077502 | Unknown

• 1 other identifier: CharlesUniversityPragueCR
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Binge-Eating Disorder

Keywords

binge eating disorder; craving; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• The degree of craving

  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

  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

Study Arms (2)

stimulated group

ACTIVE COMPARATOR

The group stimulated by real coil of rTMS.

Device: Repetitive Transcranial Magnetic Stimulation

controle group

SHAM COMPARATOR

The group stimulated by sham coil of rTMS.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Repetitive Transcranial Magnetic Stimulation

controle group; stimulated group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Related Publications (10)

• Baczynski TP, de Aquino Chaim CH, Nazar BP, Carta MG, Arias-Carrion O, Silva AC, Machado S, Nardi AE. High-frequency rTMS to treat refractory binge eating disorder and comorbid depression: a case report. CNS Neurol Disord Drug Targets. 2014;13(5):771-5. doi: 10.2174/1871527313666140307154823.

  PMID: 24606720 BACKGROUND

• Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.

  PMID: 17187897 BACKGROUND

• Cepeda-Benito A, Gleaves DH, Fernandez MC, Vila J, Williams TL, Reynoso J. The development and validation of Spanish versions of the State and Trait Food Cravings Questionnaires. Behav Res Ther. 2000 Nov;38(11):1125-38. doi: 10.1016/s0005-7967(99)00141-2.

  PMID: 11060941 BACKGROUND

• Downar J, Sankar A, Giacobbe P, Woodside B, Colton P. Unanticipated Rapid Remission of Refractory Bulimia Nervosa, during High-Dose Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex: A Case Report. Front Psychiatry. 2012 Apr 20;3:30. doi: 10.3389/fpsyt.2012.00030. eCollection 2012.

  PMID: 22529822 BACKGROUND

• Gay A, Jaussent I, Sigaud T, Billard S, Attal J, Seneque M, Galusca B, Van Den Eynde F, Massoubre C, Courtet P, Guillaume S. A Lack of Clinical Effect of High-frequency rTMS to Dorsolateral Prefrontal Cortex on Bulimic Symptoms: A Randomised, Double-blind Trial. Eur Eat Disord Rev. 2016 Nov;24(6):474-481. doi: 10.1002/erv.2475. Epub 2016 Sep 15.

  PMID: 27633286 BACKGROUND

• McClelland J, Bozhilova N, Nestler S, Campbell IC, Jacob S, Johnson-Sabine E, Schmidt U. Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. Eur Eat Disord Rev. 2013 Nov;21(6):500-6. doi: 10.1002/erv.2266.

  PMID: 24155247 BACKGROUND

• McClelland J, Kekic M, Bozhilova N, Nestler S, Dew T, Van den Eynde F, David AS, Rubia K, Campbell IC, Schmidt U. A Randomised Controlled Trial of Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Anorexia Nervosa. PLoS One. 2016 Mar 23;11(3):e0148606. doi: 10.1371/journal.pone.0148606. eCollection 2016.

  PMID: 27008620 BACKGROUND

• Uher R, Yoganathan D, Mogg A, Eranti SV, Treasure J, Campbell IC, McLoughlin DM, Schmidt U. Effect of left prefrontal repetitive transcranial magnetic stimulation on food craving. Biol Psychiatry. 2005 Nov 15;58(10):840-2. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8.

  PMID: 16084855 BACKGROUND

• Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.

  PMID: 20060105 BACKGROUND

• Jassova K, Albrecht J, Papezova H, Anders M. Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Depression and Anxiety in a Patient with Anorexia Nervosa. Med Sci Monit. 2018 Jul 30;24:5279-5281. doi: 10.12659/MSM.908250.

  PMID: 30057403 RESULT

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants in control group were stimulated by sham repetitive transcranial magnetic stimulation coil. The investigator did not know if the participants were stimulated by real or sham coil. Stimulation was provided by other member of invetigation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized double blinde and placebo controlled

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 4, 2019
• Study Start: January 23, 2014
• Primary Completion: August 1, 2018
• Study Completion: December 31, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share