The Effect of iTBS on the Inhibition Control Function of BN

NCT05186441 | Unknown

• 1 other identifier: 20210712-SFPeng-YChen
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pathological out-of-control behavior is the core clinical symptom of Bulimia nervosa (BN). The study of its neural circuits and biological mechanism is very important to explore new intervention targets. Previous studies have found that the patients with BN have inhibitory control impairment, which may be the basis of uncontrolled binge eating and purging behaviors of BN. The study found that the cognitive decision-making dysfunction of substance addicts may lead to behavior solidification. At present, there is no related research on the cognitive decision-making model of BN. Previous studies of applicants have found that there is an enhancement in goal-oriented decision-making in BN, which may explain the binge eating and purging behaviors aimed at weight control. In addition, BN patients have obvious impulsiveness, and the individuals of BN often feel unable to control eating behavior , and experience obvious sense of out of control. The previous study confirmed that untreated BN patients were highly impulsive and had inhibitory control disorders. Inhibition and control disorder is one of the important pathogenesis of BN. Previous studies indicated that dorsolateral prefrontal cortex (DLPFC) and dorsomedial prefrontal cortex (DMPFC) were associated with aboved symptoms. In this study, the patients with BN were selected as subjects. A randomized, single-blind cohort study was designed to observe the effect of iTBS intervention of DLPFC or DMPFC on pathological out-of-control behavior. Combined with behavioral, neuroimaging and genetic techniques, the investigators focused on the function of the prefrontal lobe-striatum neural circuits dopamine system. By the objective markers of peripheral, brain imaging and behavior of BN, to provide new targets and ideas for the treatment of BN.

Conditions

Feeding and Eating Disorders

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Examination(EDE-Q)

  EDE-Q can evaluate the eating disorder behavior and psychology characteristics and assess their frequency and intensity, which can assess the severity of eating disorders. The scores of the subscales are obtained by calculating the average of the items that comprise each subscale, and the global score (EDE-Q 6.0) is the average of scores of the four subscales. The higher is the score, the more severe in the ED-symptoms.

  Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,16weeks.

Secondary Outcomes (8)

• Barratt Impulsiveness Scale(BIS-II)

  Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,16weeks.

• Beck Depression Inventory-II (BDI- II)

  Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,16weeks.

• Beck Anxiety Inventory (BAI)

  Change from Baseline Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,16weeks.

• Behavioral experiment(Sequential learning task )

  Change from Baseline behaviors at 4 weeks.

• Incidence of Adverse Events [Safety and Tolerability] (i.e., seizures, etc.)

  through study completion, an average within 1 week

Study Arms (3)

DMPFC iTBS

ACTIVE COMPARATOR

DMPFC iTBS group has 30 patients. Each receive 20 times DMPFC iTBS therapy. During the iTBS, a 5-min train treatment(110%RMT, 2s on and 8s off, 900 pulses in total）was applied to the left DMPFC.

Other: DMPFC iTBS

DLPFC iTBS

ACTIVE COMPARATOR

DLPFC iTBS group has 30 patients. Each receive 20 times DMPFC iTBS therapy. During the iTBS, a 5-min train treatment(110%RMT, 2s on and 8s off, 900 pulses in total）was applied to the left DMPFC.

Other: DLPFC iTBS

placebo

SHAM COMPARATOR

The placebo research received similar pseudo-stimulation treatment, which was the same as the treatment site and method of true stimulation, but during stimulation, the coil used B65 8 zigzag coil, which was flipped 180 degrees, and only produced stimulation sound during treatment, but did not produce irritating magnetic field. It can produce a placebo effect.

Other: DMPFC iTBS; Other: DLPFC iTBS

Interventions

DMPFC iTBS OTHER

The intermittent theta-burst stimulation (iTBS) (i.e. two excitatory intervention paradigm) to target DMFPC can improve out-of-control behavior and decision-making model.

DMPFC iTBS; placebo

DLPFC iTBS OTHER

The intermittent theta-burst stimulation (iTBS) to target DLFPC (i.e. region within the executive control network) can effectively reduce craving, which is probably associated with enhancement of executive function.

DLPFC iTBS; placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female,
• Han nationality;
• right-handed;
• meet the diagnostic criteria of DSM-5 bulimia nervosa, body mass index (BMI) ≥ 18.5kg / m2;
• education level of junior high school or above, sufficient audiovisual level to complete the necessary examination of the study.
• Before entering the group, he has received fluoxetine treatment, the dose has been stable for one month, and has not received any form of physiotherapy (such as electroconvulsive therapy) within one month;
• each patient must understand the nature of this study and sign an informed consent form.

You may not qualify if:

• Patients who meet the diagnosis of DSM-5 other than BN, such as substance abuse / dependence, bipolar disorder, high risk of suicide, strong destructive impulses or antisocial behaviors;
• complicated with severe organic diseases and cognitive impairment, make it impossible for patients to complete the required symptom assessment and psychological tests;
• have a history of brain trauma or brain disease, epilepsy, etc. Those who have been exposed to ECT or MECT within 1 month;
• those with intracranial metal materials or pacemakers, implanted metal objects in vivo;
• those who are pregnant or planned pregnancy, women of childbearing age who are positive in pregnancy test.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• SuFang Peng, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SuFang Peng, PhD

CONTACT

862134773552; sufangpeng@126.com

Yan Chen, Master

CONTACT

862152219017; chenyan56@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor of Psychosomatic Department in Shanghai Mental Health

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: January 11, 2022
• Study Start: July 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)