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RecruitingNCT06802952

RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

RTMS for Clinical High-risk Syndrome of Psychosis Based on Personalized Targets Using Magnetoencephalography

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
26 (estimated)
Sponsor
Shanghai Mental Health Center · Academic / Other
Sex
All
Age
13 Years – 35 Years
Healthy volunteers
Not accepted

Summary

This study is an before-after study in the same subject, which enrolled 26 individuals with high-risk psychiatric syndrome (CHR). The target of subjects intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period or not yet taking antipsychotic medication. The investigators assume that the intervention targets for each CHR subject are individualized.

Detailed description

This study is divided into two parts: 1. Target determination. Firstly, MEG data of the subject's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the subject's abnormal signals in the brain, which is then used as the intervention target. Based on the subject's tolerance for single day intervention, the appropriate number of targets is generally 2-4. The upper limit of targets is 4. 2. RTMS individualized intervention. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour. The pseudo stimulation intervention lasted for 10 days in the first and second weeks, and the scale was evaluated after the end of the pseudo stimulation. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. 2-4 targets per day, 23 minutes per target, with 30-60 minutes between interventions for each target. After the fourth week, evaluate the scale. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th day after intervention. By analyzing and evaluating data, explore individualized treatment plans for CHR in clinical practice.

Conditions

Interventions

TypeNameDescription
DEVICErTMSRTMS using pseudo stimulus intervention in weeks 1-2, for a total of 10 days. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour.

Timeline

Start date
2025-02-07
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2025-01-31
Last updated
2025-02-11

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06802952. Inclusion in this directory is not an endorsement.