Feeding and Eating DisordersNCT06152640
A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC
A study testing Deep transcranial magnetic stimulation and Basic treatment in people with Feeding and Eating Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Hypothesis of "AN-ACC pathological network" suggests that ACC overactivation and abnormal functional connectivity with other brain regions is the neuropathological mechanism for the onset of AN. Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. 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 and Basic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 31 May 2026
- 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
- 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.
China1 site, 1 recruiting
- Recruiting
Jue Chen
Shanghai, Shanghai Municipality, 200030
Jue Chen, Ph.D, +8618017311203, chenjue2088@163.com
Yijun Li, 021-34773523, kjksmhc@yeah.net
About this study
Official title: A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC: A Multicenter Randomized Controlled Study
Hypothesis of "AN-ACC pathological network" suggests that ACC overactivation and abnormal functional connectivity with other brain regions is the neuropathological mechanism for the onset of AN. Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by 6-week intervention and half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model, which will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.
Read the detailed description
Building on the previous foundation and literature review, we found that ACC is closely related to the core symptoms of AN, and proposed the hypothesis of "AN-ACC pathological network", suggesting that ACC overactivation and abnormal functional connectivity with other brain regions (anterior frontal lobe, parietal lobe, precuneus, and striatum) is the neuropathological mechanism for the onset of AN.
Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by a 28-day intervention (once a day) and 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. Efficacy is judged by a weight gain of 4 kg in the four weeks following the intervention. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model. We will explore factors predictive of dTMS efficacy in AN patients of dTMS treatment group, divided into two groups according to whether dTMS is effective or not after treatment (defined as a weight gain of 4 kg in the four weeks following the intervention), using pre-treatment (baseline) demographic information, psychological assessment questionnaires, and neuroimaging data in the two groups. This will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.
- Conditions
- Feeding and Eating Disorders
- Being tested
- Deep transcranial magnetic stimulation, 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
Neuronavigation: The coil is positioned 4cm in front of the scalp point and foot motor cortex, corresponding to the ACC. The Brainways H7 coil with fluid cooling is used to obtain a greater depth of stimulation, up to about 6 cm below the cortex.
dTMS intervention: The intervention targets are at the left and right ACC, once per day, for 28 days. A total of 28 treatments are given. Stimulation mode: stimulation frequency 1Hz, stimulation intensity 100% RMT, number of pulses 150, sequence interval 20s, total 6 trials, 900 pulses.
Sham deep transcranial magnetic stimulationDevice
Neuronavigation: The sham coil is positioned 4 cm in front of the scalp point and foot motor cortex, corresponding to the ACC.
Sham dTMS intervention: The intervention targets are at the left and right ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field), once per day, for 28 days. A total of 28 treatments are given.
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 |
|---|---|---|
| dTMS treatment group | Experimental | dTMS treatment group has 40 patients with dTMS intervention using real coils, targeting ACC, given once per day, for 28 days, with a total of 28 treatments. Receives: Device: Deep transcranial magnetic stimulation; Other: Basic treatment |
| pseudo-stimulation group | Sham comparator | Pseudo-stimulation group has 40 patients with dTMS intervention using 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 once per day, for 28 days, with a total of 28 treatments. Receives: 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: whin 4 weeks after completion of treatment
Secondary outcomes (7)
1.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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
2.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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
3.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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
4.Beck Anxiety Inventory (BAI)
The BAI consists of 21 items and assesses the patient's accompanying feelings of anxiety over the past 1 week.
Measured: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
5. 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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
6. 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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
7. 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: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start30 Apr 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Huadong Hospital, Shanghai University of Traditional Chinese Medicine
- 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
- NCT06152640
- Sponsor's protocol ID
- SHDC12023122
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and baseline characteristics of participants.
Publications
Kodama N, Moriguchi Y, Takeda A, Maeda M, Ando T, Kikuchi H, Gondo M, Adachi H, Komaki G. Neural correlates of body comparison and weight estimation in weight-recovered anorexia nervosa: a functional magnetic resonance imaging study. Biopsychosoc Med. 2018 Oct 31;12:15. doi: 10.1186/s13030-018-0134-z. eCollection 2018.
PubMed 30450124King JA, Bernardoni F, Geisler D, Ritschel F, Doose A, Pauligk S, Pasztor K, Weidner K, Roessner V, Smolka MN, Ehrlich S. Intact value-based decision-making during intertemporal choice in women with remitted anorexia nervosa? An fMRI study. J Psychiatry Neurosci. 2020 Mar 1;45(2):108-116. doi: 10.1503/jpn.180252.
PubMed 31595737Yuan S, Wu H, Wu Y, Xu H, Yu J, Zhong Y, Zhang N, Li J, Xu Q, Wang C. Neural Effects of Cognitive Behavioral Therapy in Psychiatric Disorders: A Systematic Review and Activation Likelihood Estimation Meta-Analysis. Front Psychol. 2022 May 3;13:853804. doi: 10.3389/fpsyg.2022.853804. eCollection 2022.
PubMed 35592157Bersani FS, Minichino A, Enticott PG, Mazzarini L, Khan N, Antonacci G, Raccah RN, Salviati M, Delle Chiaie R, Bersani G, Fitzgerald PB, Biondi M. Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: a comprehensive review. Eur Psychiatry. 2013 Jan;28(1):30-9. doi: 10.1016/j.eurpsy.2012.02.006. Epub 2012 May 3.
PubMed 22559998Roth Y, Tendler A, Arikan MK, Vidrine R, Kent D, Muir O, MacMillan C, Casuto L, Grammer G, Sauve W, Tolin K, Harvey S, Borst M, Rifkin R, Sheth M, Cornejo B, Rodriguez R, Shakir S, Porter T, Kim D, Peterson B, Swofford J, Roe B, Sinclair R, Harmelech T, Zangen A. Real-world efficacy of deep TMS for obsessive-compulsive disorder: Post-marketing data collected from twenty-two clinical sites. J Psychiatr Res. 2021 May;137:667-672. doi: 10.1016/j.jpsychires.2020.11.009. Epub 2020 Nov 4.
PubMed 33183769Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.
PubMed 28927961Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
PubMed 31109199Lipsman N, Lam E, Volpini M, Sutandar K, Twose R, Giacobbe P, Sodums DJ, Smith GS, Woodside DB, Lozano AM. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial. Lancet Psychiatry. 2017 Apr;4(4):285-294. doi: 10.1016/S2215-0366(17)30076-7. Epub 2017 Feb 24.
PubMed 28238701Karaszewska D, Cleintuar P, Oudijn M, Lok A, van Elburg A, Denys D, Mocking R. Efficacy and safety of deep brain stimulation for treatment-refractory anorexia nervosa: a systematic review and meta-analysis. Transl Psychiatry. 2022 Aug 15;12(1):333. doi: 10.1038/s41398-022-02102-w.
PubMed 35970847
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06152640
- Acronym / sponsor ID
- SHDC12023122
- Conditions
- Feeding and Eating Disorders
- Keywords
- anorexia nervosa, Deep transcranial magnetic stimulation, anterior cingulate cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Huadong Hospital, Shanghai University of Traditional Chinese Medicine
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Dec 2023 (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.
Hypothesis of "AN-ACC pathological network" suggests that ACC overactivation and abnormal functional connectivity with other brain regions is the neuropathological mechanism for the onset of AN. Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by 6-week intervention and half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model, which will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.
Detailed description
Building on the previous foundation and literature review, we found that ACC is closely related to the core symptoms of AN, and proposed the hypothesis of "AN-ACC pathological network", suggesting that ACC overactivation and abnormal functional connectivity with other brain regions (anterior frontal lobe, parietal lobe, precuneus, and striatum) is the neuropathological mechanism for the onset of AN.
Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by a 28-day intervention (once a day) and 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. Efficacy is judged by a weight gain of 4 kg in the four weeks following the intervention. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model. We will explore factors predictive of dTMS efficacy in AN patients of dTMS treatment group, divided into two groups according to whether dTMS is effective or not after treatment (defined as a weight gain of 4 kg in the four weeks following the intervention), using pre-treatment (baseline) demographic information, psychological assessment questionnaires, and neuroimaging data in the two groups. This will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dTMS treatment group | Experimental | Device: Deep transcranial magnetic stimulation, Other: Basic treatmentdTMS treatment group has 40 patients with dTMS intervention using real coils, targeting ACC, given once per day, for 28 days, with a total of 28 treatments. |
| pseudo-stimulation group | Sham comparator | Device: Sham deep transcranial magnetic stimulation, Other: Basic treatmentPseudo-stimulation group has 40 patients with dTMS intervention using 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 once per day, for 28 days, with a total of 28 treatments. |
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 stimulationNeuronavigation: The coil is positioned 4cm in front of the scalp point and foot motor cortex, corresponding to the ACC. The Brainways H7 coil with fluid cooling is used to obtain a greater depth of stimulation, up to about 6 cm below the cortex. dTMS intervention: The intervention targets are at the left and right ACC, once per day, for 28 days. A total of 28 treatments are given. Stimulation mode: stimulation frequency 1Hz, stimulation intensity 100% RMT, number of pulses 150, sequence interval 20s, total 6 trials, 900 pulses. | Device | dTMS treatment group |
| Sham deep transcranial magnetic stimulationNeuronavigation: The sham coil is positioned 4 cm in front of the scalp point and foot motor cortex, corresponding to the ACC. Sham dTMS intervention: The intervention targets are at the left and right ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field), once per day, for 28 days. A total of 28 treatments are given. | Device | 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 | dTMS treatment group, pseudo-stimulation group |
Primary outcome
Body Mass Index (BMI).
Time frame: whin 4 weeks after completion of treatment
Calculation: BMI = weight (kg) divided by the square of height (m)
7 secondary outcomes
1.Eating Disorder Examination Questionnaire (EDE-Q6.0)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
2.Eating Disorder Inventory (EDI-II)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
3.Beck Depression Inventory (BDI)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
4.Beck Anxiety Inventory (BAI)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
5. Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
6. Body Image Tasks
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
7. Delay Discounting Task (DDT task)
Time frame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 30450124Kodama N, Moriguchi Y, Takeda A, Maeda M, Ando T, Kikuchi H, Gondo M, Adachi H, Komaki G. Neural correlates of body comparison and weight estimation in weight-recovered anorexia nervosa: a functional magnetic resonance imaging study. Biopsychosoc Med. 2018 Oct 31;12:15. doi: 10.1186/s13030-018-0134-z. eCollection 2018.
- Background: PubMed 31595737King JA, Bernardoni F, Geisler D, Ritschel F, Doose A, Pauligk S, Pasztor K, Weidner K, Roessner V, Smolka MN, Ehrlich S. Intact value-based decision-making during intertemporal choice in women with remitted anorexia nervosa? An fMRI study. J Psychiatry Neurosci. 2020 Mar 1;45(2):108-116. doi: 10.1503/jpn.180252.
- Background: PubMed 35592157Yuan S, Wu H, Wu Y, Xu H, Yu J, Zhong Y, Zhang N, Li J, Xu Q, Wang C. Neural Effects of Cognitive Behavioral Therapy in Psychiatric Disorders: A Systematic Review and Activation Likelihood Estimation Meta-Analysis. Front Psychol. 2022 May 3;13:853804. doi: 10.3389/fpsyg.2022.853804. eCollection 2022.
- Background: PubMed 22559998Bersani FS, Minichino A, Enticott PG, Mazzarini L, Khan N, Antonacci G, Raccah RN, Salviati M, Delle Chiaie R, Bersani G, Fitzgerald PB, Biondi M. Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: a comprehensive review. Eur Psychiatry. 2013 Jan;28(1):30-9. doi: 10.1016/j.eurpsy.2012.02.006. Epub 2012 May 3.
- Background: PubMed 33183769Roth Y, Tendler A, Arikan MK, Vidrine R, Kent D, Muir O, MacMillan C, Casuto L, Grammer G, Sauve W, Tolin K, Harvey S, Borst M, Rifkin R, Sheth M, Cornejo B, Rodriguez R, Shakir S, Porter T, Kim D, Peterson B, Swofford J, Roe B, Sinclair R, Harmelech T, Zangen A. Real-world efficacy of deep TMS for obsessive-compulsive disorder: Post-marketing data collected from twenty-two clinical sites. J Psychiatr Res. 2021 May;137:667-672. doi: 10.1016/j.jpsychires.2020.11.009. Epub 2020 Nov 4.
- Background: PubMed 28927961Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.
- Background: PubMed 31109199Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
- Background: PubMed 28238701Lipsman N, Lam E, Volpini M, Sutandar K, Twose R, Giacobbe P, Sodums DJ, Smith GS, Woodside DB, Lozano AM. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial. Lancet Psychiatry. 2017 Apr;4(4):285-294. doi: 10.1016/S2215-0366(17)30076-7. Epub 2017 Feb 24.
- Background: PubMed 35970847Karaszewska D, Cleintuar P, Oudijn M, Lok A, van Elburg A, Denys D, Mocking R. Efficacy and safety of deep brain stimulation for treatment-refractory anorexia nervosa: a systematic review and meta-analysis. Transl Psychiatry. 2022 Aug 15;12(1):333. doi: 10.1038/s41398-022-02102-w.
- Individual participant dataSharing planned: Yes. The study protocol and baseline characteristics of participants.
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Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
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.
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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 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: whin 4 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152640, which also lists 9 linked publications.
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 26 Apr 2024.