Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02180984
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2014-06-25
Brief Title:
The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
The Effects of Repetitive Transcranial Magnetic Stimulation in Obese Females With Binge Eating Disorder a Protocol for a Double-blinded Randomized Sham-controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30 or placebo n30 scattered 3 daysweek
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
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 n30 or placebo n30 scattered 3 daysweek
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 n30 or placebo n30 scattered 3 daysweek
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 26164614700005505 | OTHER | CEP UNIFESP | None |