Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)

Binge-Eating Disorder Clinical Trial

— TMS&BED  

Official title:

Effect of the Transcranial Magnetic Stimulation Applied on the Left Dorsolateral Prefrontal Cortex on the Clinical and Neuropsychological Variables in Subjects With Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540641
• Other study ID #: 9320
• Status: Completed
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2019
• Source: Universidad Autonoma de Queretaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.

Description:

Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Subjects of both sexes.

2. Subjects from 18 to 45 years of age.

3. Subjects with diagnosis of binge eating disorder.

4. Subjects without changes in pharmacological treatment in the last 30 days.

5. Subjects who agree to sign the informed consent letter.

Exclusion Criteria:

1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.

3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).

4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence.

5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

Device:
• MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz

Locations

Country	Name	City	State
Mexico	Sofía Cañizares Gómez.	Querétaro City	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Amianto F, Ottone L, Abbate Daga G, Fassino S. Binge-eating disorder diagnosis and treatment: a recap in front of DSM-5. BMC Psychiatry. 2015 Apr 3;15:70. doi: 10.1186/s12888-015-0445-6. Review. — View Citation

Barth KS, Rydin-Gray S, Kose S, Borckardt JJ, O'Neil PM, Shaw D, Madan A, Budak A, George MS. Food cravings and the effects of left prefrontal repetitive transcranial magnetic stimulation using an improved sham condition. Front Psychiatry. 2011 Mar 14;2:9 — View Citation

Lefaucheur JP, André-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jääskeläinen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, P — View Citation

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, — View Citation

Orozco-Cabal LF, Herin D. Neurobiología de la impulsividad y los trastornos de la conducta alimentaria. Rev Colomb Psiquiatr. 2008 Jun 1;37(2):207-219. Spanish. — View Citation

Uher R, Rutter M. Classification of feeding and eating disorders: review of evidence and proposals for ICD-11. World Psychiatry. 2012 Jun;11(2):80-92. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Craving Inventory (FCI)	The FCI is a self-report inventory designed to measure the food craving, is made up of 37 elements and is a scale-likert instrument.	6 weeks
Secondary	Barratt Impulsivity Scale (BIS-11)	The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness is composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .	6 weeks