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NCT04513132
Targeted Intervention Study of DTMS on Impaired Insight in Early Psychosis
NA trial testing active-dTMS in Impaired Insight. Withdrawn.
31 December 2025
Quick facts
| Lead sponsor | Shanghai Mental Health Center |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 1 January 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- active-dTMS
- sham-dTMS
Conditions studied
- Impaired Insight — all drugs for Impaired Insight →
Sponsor
Shanghai Mental Health Center — full company profile →
Who can join
Adults 15 to 35, any sex, with Impaired Insight. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia, but there is a lack of targeted interventions. We found that an electroencephalogram (EEG) signal reflecting the function of self monitoring was a potential objective marker of impaired insight. And further functional magnetic resonance imaging (fMRI) analysis showed that the functional connectivity between anterior cingulate gyrus (ACC) and medial temporal gyrus (MTG) was related to insight. Studies have shown that ACC theta oscillation is the key to self monitoring, and theta-alpha phase synchronization between frontotemporal is closely related to cognition. Therefore, this project hypothesized that targeted regulation of ACC theta oscillations could promote theta-alpha phase synchronization and functional connectivity between ACC and MTG, thereby improving patients' insight. The first-episode and high-risk subjects were recruited to detect the theta oscillation of ACC, theta-Alpha phase synchronization and functional connectivity between ACC and MTG using EEG-fMRI. Deep transcranial magnetic stimulation was introduced to regulate ACC theta oscillations. The high-risk subjects were followed up for two years. It was estimated that the theta-alpha phase synchronization of ACC-MTG and insight in the active-dTMS group were significantly improved. And the outcome of the high-risk subjects is better. The project develops neuroregulatory techniques for impaired insight of schizophrenia and is expected to provide a solution for this clinical pain point.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04513132
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Related trials
Other trials of active-dTMS
Trials testing the same drug.
- NCT06831877 — Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight · NA · recruiting
Other recruiting trials for Impaired Insight
Currently open trials in the same condition.
- NCT06831877 — Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight · NA · recruiting
Other Shanghai Mental Health Center trials
Trials by the same sponsor.
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- NCT07479771 — tTIS Targeted of the Striatum as an Intervention for MUD Patients · NA · not yet recruiting
- NCT07472673 — Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Pati · NA · not yet recruiting
- NCT07484750 — Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD · NA · recruiting
- NCT07311655 — Validation of the Accuracy of an AI-Based System for Diagnosing Anxiety Disorders · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04513132 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
- Last refreshed: 24 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04513132.
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