Feeding and Eating DisordersNCT06942858
Mechanisms of Deep Transcranial Magnetic Stimulation in Enhancing Cognitive-Behavioral Therapy for Anorexia Nervosa
A study testing Deep transcranial magnetic stimulation, cognitive behavior therapy and Basic treatment in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- Deep transcranial magnetic stimulation, cognitive behavior therapy and Basic treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged 18-35 years, right handedness.
- Above primary education.
- Meet the diagnostic criteria of AN in DSM-V, and13.0 kg/m2 ≤ body mass index (BMI)<18.5 kg/m2.
- No systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment.
- Able to understand the nature of this study and sign an informed consent form.
Who cannot join
- Diagnosed with a DSM-5 disease other than anorexia nervosa, or at high risk of suicide, strong impulsive behavior as well as anti-social behavior.
- With severe physical or cognitive impairment.
- Not able to undergo MRI.
- Considered unsuitable for enrollment in this clinical trial for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health
Shanghai, Shanghai Municipality, 200030
Jue Chen, PHD, +8618017311203, chenjue2088@163.com
About this study
Official title: Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa
The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether CBT combined with dTMS is superior to single CBT treatment for AN.
Read the detailed description
The investigators propose hypothesis that CBT improves AN symptoms by modulating the "AN-ACC pathology network", and that high-frequency stimulation targeting the ACC by dTMS can synergize "AN-ACC pathology network" and enhance the efficacy of CBT. In order to verify this hypothesis, a randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by 6-week intervention and a half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Patients in both groups undergo fMRI examinations, complete delay discounting task (DDT) and body image task before and after each treatment session. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, week 6 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). This study will provide a theoretical and practical basis for the innovative combined intervention method in patients with AN, and to verify the "AN-ACC pathological network" pathomechanism of AN at multiple levels.
- Conditions
- Feeding and Eating Disorders
- Being tested
- Deep transcranial magnetic stimulation, cognitive behavior therapy, Sham deep transcranial magnetic stimulation, Basic treatment
- Keywords
- anorexia nervosa, Deep transcranial magnetic stimulation, anterior cingulate cortex
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep transcranial magnetic stimulationDevice
M-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC. A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The coil is an integrated coil for true and false stimulation loops. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.
cognitive behavior therapyBehavioural
Each patient receives 12 individual sessions of 50 minutes twice a week for 6 weeks.The CBT therapists are nationally registered psychotherapists with systematic professional training and uniform training in CBT for anorexia nervosa to ensure consistency. They are also supervised by a CBT supervisor at the end of each session.
Sham deep transcranial magnetic stimulationDevice
M-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.
Basic treatmentOther
According to national and international guidelines for the treatment of eating disorders, the basic treatment for patients is nutritional therapy, that is, regular and quantitative dietary treatment, with three regular meals followed by a snack meal 2 hours after the regular meal. Both groups received the same nutritional treatment.
| Study group | Role | What they receive |
|---|---|---|
| CBT+dTMS treatment group | Experimental | CBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks. Receives: Device: Deep transcranial magnetic stimulation; Behavioral: cognitive behavior therapy; Other: Basic treatment |
| CBT+pseudo-stimulation group | Active comparator | CBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks. Receives: Behavioral: cognitive behavior therapy; Device: Sham deep transcranial magnetic stimulation; Other: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Calculation: BMI = weight (kg) divided by the square of height (m)
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Secondary outcomes (7)
Eating Disorder Examination Questionnaire (EDE-Q6.0)
Eating Disorder Examination Questionnaire can assess the core symptoms of eating disorders, including behavioral and psychological characteristics, and rate their frequency and intensity, which can assess the severity of the eating disorder. It consists of 4 subscales, including dietary restriction, eating concerns, body image concerns, and weight concerns.
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Eating Disorder Inventory (EDI-II)
It is a commonly used scale for assessing cognitive-behavioral symptoms of eating disorders and is used to assess the severity of eating disorders. The scale contains 91 items divided into 8 subscales and 3 temporary subscales, including the pursuit of thinness, bulimia, body dissatisfaction, feelings of ineffectiveness, perfectionism, mistrust of others, introspection, maturity fears, abstinence, impulsive regulation and social insecurity.
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Beck Depression Inventory (BDI)
The BDI consists of 21 items and assesses the patient's accompanying feelings of depression over the past 2 weeks.
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a self-rating scale used to assess a patient's anxiety symptoms. The scale consists of 21 items, each evaluating the degree of distress caused by anxiety symptoms. It uses a four-point scale from 1 to 4, with 1 indicating no symptoms and 4 indicating severe symptoms. The total score ranges from a minimum of 21 to a maximum of 84, with higher scores indicating more severe anxiety symptoms.
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)
The SR-YBC-EDS was developed based on the Yale-Brown Compulsive Questionnaire for Eating Disorders (YBC-EDS), consisting of two parts: the first part is a list of 65 symptomatic items, which is used to identify the subjects' obsessive-compulsive symptoms, and the second part is a list of 8 core items, which is used to assess the frequency and severity of obsessive-compulsive symptoms. All parts contain two dimensions: preoccupation and ritual behavior.
Measured: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Body Image Tasks
Tasks that address excessive concerns about body shape/weight include the following two parts: Body size estimation: The screen will present the above 30 body size pictures sequentially, the subjects will view the body size pictures in 4000ms, and then evaluate the body size of the body pictures in 4000ms, with a score of 1 representing "very low body weight", 4 representing "very overweight", and 4 representing "very overweight". A score of 1 represents "very low weight" and a score of 4 represents "very overweight". Body compare task: The screen will present the above 30 body images in turn, the subjects will have 4000ms to view their own images (with randomized distortions), and then they will have 4000ms to compare their actual body shape with the body shape in the images and assess their emotional level. 1 point represents "very calm" and 4 for "very anxious".
Measured: week 0（baseline）, ,week 6（post-intervention）
Delay Discounting Task (DDT task)
The study uses a DDT task in a food choice scenario to assess inhibitory impulses. The task requires subjects to make a decision between choosing a small reward in the present or a large reward in the future. Inhibition to choose a small reward in the present implies a strong intertemporal decision-making ability. The task begins with an assessment of their hunger, willingness to eat, and emotional feelings at the moment. Then they are asked to rate 40 pictures of food on a scale of 0 to 10 on five dimensions: familiarity, craving, positive and negative emotions, emotional intensity, and eating control. Pictures of foods with craving scores >7 and eating control <5, as well as matched in familiarity and emotion for use in the ensuing delay discounting task. The choice is made by pressing a button: Patients choosing to get less food immediately are given fewer coupons after the delay. But those waiting for a period of time to get more food are given more coupons after the delay.
Measured: week 0（baseline）, week 6（post-intervention）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
- Investigators
- Jue Chen, PHD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942858
- Sponsor's protocol ID
- 82471573
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06942858
- Acronym / sponsor ID
- 82471573
- Conditions
- Feeding and Eating Disorders
- Keywords
- anorexia nervosa, Deep transcranial magnetic stimulation, anterior cingulate cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Apr 2025 (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.
The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether CBT combined with dTMS is superior to single CBT treatment for AN.
Detailed description
The investigators propose hypothesis that CBT improves AN symptoms by modulating the "AN-ACC pathology network", and that high-frequency stimulation targeting the ACC by dTMS can synergize "AN-ACC pathology network" and enhance the efficacy of CBT. In order to verify this hypothesis, a randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by 6-week intervention and a half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Patients in both groups undergo fMRI examinations, complete delay discounting task (DDT) and body image task before and after each treatment session. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, week 6 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). This study will provide a theoretical and practical basis for the innovative combined intervention method in patients with AN, and to verify the "AN-ACC pathological network" pathomechanism of AN at multiple levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT+dTMS treatment group | Experimental | Device: Deep transcranial magnetic stimulation, Behavioral: cognitive behavior therapy, Other: Basic treatmentCBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks. |
| CBT+pseudo-stimulation group | Active comparator | Behavioral: cognitive behavior therapy, Device: Sham deep transcranial magnetic stimulation, Other: Basic treatmentCBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, aged 18-35 years, right handedness.
- Above primary education.
- Meet the diagnostic criteria of AN in DSM-V, and13.0 kg/m2 ≤ body mass index (BMI)<18.5 kg/m2.
- No systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment.
- Able to understand the nature of this study and sign an informed consent form.
Key exclusion criteria (4 listed)
- Diagnosed with a DSM-5 disease other than anorexia nervosa, or at high risk of suicide, strong impulsive behavior as well as anti-social behavior.
- With severe physical or cognitive impairment.
- Not able to undergo MRI.
- Considered unsuitable for enrollment in this clinical trial for other reasons.
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 |
|---|---|---|
| Deep transcranial magnetic stimulationM-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC. A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The coil is an integrated coil for true and false stimulation loops. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively. | Device | CBT+dTMS treatment group |
| cognitive behavior therapyEach patient receives 12 individual sessions of 50 minutes twice a week for 6 weeks.The CBT therapists are nationally registered psychotherapists with systematic professional training and uniform training in CBT for anorexia nervosa to ensure consistency. They are also supervised by a CBT supervisor at the end of each session. | Behavioural | CBT+dTMS treatment group, CBT+pseudo-stimulation group |
| Sham deep transcranial magnetic stimulationM-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively. | Device | CBT+pseudo-stimulation group |
| Basic treatmentAccording to national and international guidelines for the treatment of eating disorders, the basic treatment for patients is nutritional therapy, that is, regular and quantitative dietary treatment, with three regular meals followed by a snack meal 2 hours after the regular meal. Both groups received the same nutritional treatment. | Other | CBT+dTMS treatment group, CBT+pseudo-stimulation group |
Primary outcome
Body Mass Index (BMI)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Calculation: BMI = weight (kg) divided by the square of height (m)
7 secondary outcomes
Eating Disorder Examination Questionnaire (EDE-Q6.0)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Eating Disorder Inventory (EDI-II)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Beck Depression Inventory (BDI)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Beck Anxiety Inventory (BAI)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)
Time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Body Image Tasks
Time frame: week 0（baseline）, ,week 6（post-intervention）
Delay Discounting Task (DDT task)
Time frame: week 0（baseline）, week 6（post-intervention）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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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.
Jue Chen, 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 Deep transcranial magnetic stimulation, cognitive behavior therapy and Basic treatment 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jue Chen, PHD (+8618017311203, chenjue2088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）). 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 May 2025.