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Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder

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ClinicalTrials.gov Identifier: NCT04077502
Recruitment Status : Active, not recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Katarína Jaššová, Charles University, Czech Republic

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.


Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized double blinde and placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder. A Double Blind Placebo Controlled Study
Actual Study Start Date : January 23, 2014
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:
Other Publications:

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Responsible Party: Katarína Jaššová, Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04077502     History of Changes
Other Study ID Numbers: CharlesUniversityPragueCR
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katarína Jaššová, Charles University, Czech Republic:
binge eating disorder
craving
repetitive transcranial magnetic stimulation
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms