Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152640
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-11-16
Brief Title:
A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC A Multicenter Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None