Feeding and Eating DisordersNCT05186441
The Effect of iTBS on the Inhibition Control Function of BN
A study testing DMPFC iTBS and DLPFC iTBS in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- DMPFC iTBS and DLPFC iTBS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
SuFang Peng, PhD, 862134773549, sufangpeng@126.com
Yan Chen, Master, 862152219017, chenyan56@sina.com
About this study
Official title: The Effect of Theta Burst Stimulation on the Inhibition Control Function of Bulimia Nervosa and Relevant Mechanism Study
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.
Read the 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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- DMPFC iTBS, DLPFC iTBS
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMPFC iTBSOther
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.
DLPFC iTBSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: DMPFC iTBS; Other: DLPFC iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,16weeks.
Secondary outcomes (8)
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.
Measured: Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,16weeks.
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.
Measured: Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,16weeks.
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.
Measured: Change from Baseline Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,16weeks.
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.
Measured: Change from Baseline behaviors at 4 weeks.
Incidence of Adverse Events [Safety and Tolerability] (i.e., seizures, etc.)
The frequency of adverse events from each participant.
Measured: through study completion, an average within 1 week
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.
Measured: Change from Baseline behaviors at 4 weeks.
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.
Measured: Change from Baseline behaviors at 4 weeks.
MRI
brain activation and structure as assessed by MRI
Measured: before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jul 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sufang PENG, Shanghai Mental Health Center
- Investigators
- SuFang Peng, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186441
- Sponsor's protocol ID
- 20210712-SFPeng-YChen
- Status last verified
- Jan 2022
- First submitted
- 6 Aug 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theta Burst Stimulation on the Inhibition Control Function of Bulimia Nervosa and Relevant Mechanism Study
- ClinicalTrials.gov ID
- NCT05186441
- Acronym / sponsor ID
- 20210712-SFPeng-YChen
- Conditions
- Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DMPFC iTBS | Active comparator | Other: DMPFC iTBSDMPFC 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 | Active comparator | Other: DLPFC iTBSDLPFC 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. |
| placebo | Sham comparator | Other: DMPFC iTBS, Other: DLPFC iTBSThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMPFC iTBSThe intermittent theta-burst stimulation (iTBS) (i.e. two excitatory intervention paradigm) to target DMFPC can improve out-of-control behavior and decision-making model. | Other | DMPFC iTBS, placebo |
| DLPFC iTBSThe 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. | Other | DLPFC iTBS, placebo |
Primary outcome
Eating Disorder Examination(EDE-Q)
Time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,16weeks.
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.
8 secondary outcomes
Barratt Impulsiveness Scale(BIS-II)
Time frame: Change from Baseline the severity of impulse suppression orientation at 4 weeks,8weeks,12weeks,16weeks.
Beck Depression Inventory-II (BDI- II)
Time frame: Change from Baseline the severity of the symptoms of depression at 4 weeks,8weeks,12weeks,16weeks.
Beck Anxiety Inventory (BAI)
Time frame: Change from Baseline Baseline the severity of the symptoms of anxiety at 4 weeks,8weeks,12weeks,16weeks.
Behavioral experiment(Sequential learning task )
Time frame: Change from Baseline behaviors at 4 weeks.
Incidence of Adverse Events [Safety and Tolerability] (i.e., seizures, etc.)
Time frame: through study completion, an average within 1 week
Behavioral experiment(Stop-signal task )
Time frame: Change from Baseline behaviors at 4 weeks.
Behavioral experiment(Delay discounting task )
Time frame: Change from Baseline behaviors at 4 weeks.
MRI
Time frame: before the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SuFang Peng, PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMPFC iTBS and DLPFC iTBS in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SuFang Peng, PhD (862134773552, sufangpeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination(EDE-Q) (time frame: Change from Baseline eating attitudes and behaviors at 4 weeks,8weeks,12weeks,16weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.