Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
NCT06152640

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

Led by Shanghai Mental Health Center · Updated on 2024-04-26

80

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

S

Shanghai Mental Health Center

Lead Sponsor

S

Shanghai Tongji Hospital, Tongji University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged 18-35 years, right handedness
  • Education level above primary school
  • Diagnosed with anorexia nervosa according to DSM-V criteria
  • Body mass index (BMI) between 13.0 and less than 18.5 kg/m2
  • No nutritional therapy, psychiatric medication, or psychotherapy in the past month
  • Able to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with DSM-5 disorders other than anorexia nervosa or at high risk of suicide
  • Exhibiting strong impulsive or anti-social behavior
  • Having severe physical or cognitive impairments
  • Unable to undergo MRI scanning
  • Considered unsuitable for the trial for other reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Jue Chen

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

J

Jue Chen, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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