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The Effect of iTBS on the Inhibition Control Function of BN

Primary Purpose

Feeding and Eating Disorders

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DMPFC iTBS
DLPFC iTBS
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding and Eating Disorders

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

DMPFC iTBS

DLPFC iTBS

placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barratt Impulsiveness Scale(BIS-II)
This tool can measure the severity of impulse suppression orientation.The total score for BIS-11 ranges from 30 to 120. The higher is the score, the higher is the impulsiveness.
Beck Depression Inventory-II (BDI- II)
Depression symptoms were assessed with the BDI-II. The scale has 21-items. The total score for BDI- IIranges from 0 to 84.The higher is the score, the higher is the depression.
Beck Anxiety Inventory (BAI)
BAI is a 21-item self-report scale for assessing the symptom of anxiety. The total score for BAI ranges from 0 to 84. The higher is the score, the higher is the anxiety.
Behavioral experiment(Sequential learning task )
The spaceship task from Decker et al will be used. The task was designed to dissociate model-free and model-based learning strategies. The goal of the participants will to collect "space gems". In the first stage, the participants choose between two spaceships. The probability of each spaceship's transition to two planets is fixed. In the second stage, on each planet, participants need to choose between two aliens to obtain gems. The probability of getting a gem changes slowly at this stage. This changing reward probability encourages participants to explore different options throughout the task to maximize the reward. The behavior data will be modeled, and the hybrid reinforcement learning model will used to obtain the ratio of model-based behavior and model-free behavior in the process of individual learning decision-making.
Incidence of Adverse Events [Safety and Tolerability] (i.e., seizures, etc.)
The frequency of adverse events from each participant.
Behavioral experiment(Stop-signal task )
The stop-signal task was adjusted using as cues the two foods previously selected after the rating session. Two types of conditions were included, such as low-error condition and high-error condition. Participants performed 240 trials in total: 160 Go trials (80 for the Low-Error condition and 80 for the High-Error condition) and 80 Stop trials (40 for the Low-Error condition and 40 for the High-Error condition). The task lasted approximately 16 minutes. Data analysis will be performed on the accuracy (number of errors) and the RTs of correct responses vs. errors (no-response trials ignored), for the Low- vs. High-Error condition, and for Go vs. Stop trials.
Behavioral experiment(Delay discounting task )
The delay discounting task for monetary present choices between differing amounts of reward at varing time points (such as 2 days, 7days, 15days, 1 month, 45 days, 3 months, 6 months and 1 year), where one of the options is a smaller amount of reward available soon or immediately, and the other option is a larger amount of reward available after a longer delay. Discount rate will be estimated by fitting the indifference point data to a discounting model.
MRI
brain activation and structure as assessed by MRI

Full Information

First Posted
August 6, 2021
Last Updated
January 10, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05186441
Brief Title
The Effect of iTBS on the Inhibition Control Function of BN
Official Title
The Effect of Theta Burst Stimulation on the Inhibition Control Function of Bulimia Nervosa and Relevant Mechanism Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Bulimia nervosa(BN) is a chronic and refractory mental disorder characteristic of recurrent binge eating and weight control which mostly occur in adolescents and young women. The life-time prevalence ranges from 1.0%-4.2%, and keep increasing. Pathological out-of-control behavior is the core clinical symptom of BN. Impulsive personality trait is an important risk factor for overeating symptoms in patients with BN. Inhibition control dysfunction leads to increased impulsiveness, while impaired goal-oriented control leads to rigid behavior habits, such as obsessive-compulsive drug-seeking and drug use, resulting in pathological out-of-control behavior. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, safe and non-invasive physical intervention and nerve stimulation, which can be targeted at specific brain regions or networks, providing hope for people who do not respond well to drug therapy. iTBS stimulation mode can induce long-term potentiation of behavior and neural activity (LTP). Previous studies indicated that dorsolateral prefrontal cortex (DLPFC) and dorsomedial prefrontal cortex (DMPFC) were associated with out-of-control behavior. In this study, the investigators will recruit 90 BN patients, would randomly divided into 30 DMPFC iTBS intervention group, 30 DLPFC iTBS and 30 sham-stimulation group. 20 iTBS will be given in the intervention group at DMPFC or DLPFC. To assess the eating disorder symptoms, impulsive and emotional change, clinical symptom scales, psychological scales and the behavioral experiments will be used at baseline, 4 weeks, 8 weeks, 12 weeks and16weeks, respectively. Furthermore, brain MRI will be used for BN at baseline. This study is innovative and feasible. If the expected results can be obtained, it will lay a foundation for understanding the common mechanism behind the pathological behavior of BN and provide new directions and ideas for the design of effective intervention measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DMPFC iTBS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DLPFC iTBS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DMPFC iTBS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
DLPFC iTBS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Disorder Examination(EDE-Q)
Description
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.
Time Frame
Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,16weeks.
Secondary Outcome Measure Information:
Title
Barratt Impulsiveness Scale(BIS-II)
Description
This tool can measure the severity of impulse suppression orientation.The total score for BIS-11 ranges from 30 to 120. The higher is the score, the higher is the impulsiveness.
Time Frame
Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,16weeks.
Title
Beck Depression Inventory-II (BDI- II)
Description
Depression symptoms were assessed with the BDI-II. The scale has 21-items. The total score for BDI- IIranges from 0 to 84.The higher is the score, the higher is the depression.
Time Frame
Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,16weeks.
Title
Beck Anxiety Inventory (BAI)
Description
BAI is a 21-item self-report scale for assessing the symptom of anxiety. The total score for BAI ranges from 0 to 84. The higher is the score, the higher is the anxiety.
Time Frame
Change from Baseline Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,16weeks.
Title
Behavioral experiment(Sequential learning task )
Description
The spaceship task from Decker et al will be used. The task was designed to dissociate model-free and model-based learning strategies. The goal of the participants will to collect "space gems". In the first stage, the participants choose between two spaceships. The probability of each spaceship's transition to two planets is fixed. In the second stage, on each planet, participants need to choose between two aliens to obtain gems. The probability of getting a gem changes slowly at this stage. This changing reward probability encourages participants to explore different options throughout the task to maximize the reward. The behavior data will be modeled, and the hybrid reinforcement learning model will used to obtain the ratio of model-based behavior and model-free behavior in the process of individual learning decision-making.
Time Frame
Change from Baseline behaviors at 4 weeks.
Title
Incidence of Adverse Events [Safety and Tolerability] (i.e., seizures, etc.)
Description
The frequency of adverse events from each participant.
Time Frame
through study completion, an average within 1 week
Title
Behavioral experiment(Stop-signal task )
Description
The stop-signal task was adjusted using as cues the two foods previously selected after the rating session. Two types of conditions were included, such as low-error condition and high-error condition. Participants performed 240 trials in total: 160 Go trials (80 for the Low-Error condition and 80 for the High-Error condition) and 80 Stop trials (40 for the Low-Error condition and 40 for the High-Error condition). The task lasted approximately 16 minutes. Data analysis will be performed on the accuracy (number of errors) and the RTs of correct responses vs. errors (no-response trials ignored), for the Low- vs. High-Error condition, and for Go vs. Stop trials.
Time Frame
Change from Baseline behaviors at 4 weeks.
Title
Behavioral experiment(Delay discounting task )
Description
The delay discounting task for monetary present choices between differing amounts of reward at varing time points (such as 2 days, 7days, 15days, 1 month, 45 days, 3 months, 6 months and 1 year), where one of the options is a smaller amount of reward available soon or immediately, and the other option is a larger amount of reward available after a longer delay. Discount rate will be estimated by fitting the indifference point data to a discounting model.
Time Frame
Change from Baseline behaviors at 4 weeks.
Title
MRI
Description
brain activation and structure as assessed by MRI
Time Frame
before the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SuFang Peng, PhD
Phone
862134773552
Email
sufangpeng@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Chen, Master
Phone
862152219017
Email
chenyan56@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SuFang Peng, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SuFang Peng, PhD
Phone
862134773549
Email
sufangpeng@126.com
First Name & Middle Initial & Last Name & Degree
Yan Chen, Master
Phone
862152219017
Email
chenyan56@sina.com

12. IPD Sharing Statement

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The Effect of iTBS on the Inhibition Control Function of BN

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