A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC

NCT06152640 | Recruiting

• 1 other identifier: SHDC12023122
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Feeding and Eating Disorders

Keywords

anorexia nervosa; Deep transcranial magnetic stimulation; anterior cingulate cortex

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI).

  Calculation: BMI = weight (kg) divided by the square of height (m)

  whin 4 weeks after completion of treatment

Secondary Outcomes (7)

• 1.Eating Disorder Examination Questionnaire (EDE-Q6.0)

  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)

  baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).

• 3.Beck Depression Inventory (BDI)

  baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).

• 4.Beck Anxiety Inventory (BAI)

  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)

  baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).

Study Arms (2)

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.

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.

Device: Sham deep transcranial magnetic stimulation; Other: Basic treatment

Interventions

Deep transcranial magnetic stimulation DEVICE

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.

dTMS treatment group

Sham deep transcranial magnetic stimulation DEVICE

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.

pseudo-stimulation group

Basic treatment OTHER

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.

dTMS treatment group; pseudo-stimulation group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Huadong Hospital: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Jue Chen

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 30450124 BACKGROUND

• King 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.

  PMID: 31595737 BACKGROUND

• Yuan 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.

  PMID: 35592157 BACKGROUND

• Bersani 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.

  PMID: 22559998 BACKGROUND

• Roth 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.

  PMID: 33183769 BACKGROUND

• Carmi 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.

  PMID: 28927961 BACKGROUND

• Carmi 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.

  PMID: 31109199 BACKGROUND

• Lipsman 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.

  PMID: 28238701 BACKGROUND

• Karaszewska 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.

  PMID: 35970847 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Condition Hierarchy (Ancestors)

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

Study Officials

• Jue Chen, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jue Chen, PHD

CONTACT

+8618017311203; chenjue2088@163.com

Study Design

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

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 1, 2023
• Study Start: April 30, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Researchers will share data when the study is completed in December 2026.
• Access Criteria: dTMS; anorexia nervosa; anterior cingulate cortex

Locations

CN (1)