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Recruiting NCT06802952

RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

No phase Interventional Clinical High-risk Syndrome of Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rTMS.
Who it may be relevant to
Registry conditions: Clinical High-risk Syndrome of Psychosis. Basic parameters: 13 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device rTMS
    RTMS 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.

Primary outcome measures

  • Reduction rate of the SIPS/SOPS scale [Time frame: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.]
Secondary outcome measures (1)
  • Reduction rate of the PNASS scale [Time frame: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of Clinical High-Risk Syndrome for Psychosis
  • Must be able to right-handed
  • Primary school education or above
  • Understand and sign a written informed consent form (jointly signed by the guardian and the participant if under 18 years old)

Exclusion criteria

  • Major physical illnesses (organic lesions such as sensory and motor disorders, neurological disorders, and traumatic brain injury)
  • Taboo symptoms for rTMS treatment (such as intracranial metal implants)
  • Metal (including orthodontic treatment, dental implants) and tattoos inside the body
  • Claustrophobia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Publications

  • Tang Y, Xu L, Zhu T, Cui H, Qian Z, Kong G, Tang X, Wei Y, Zhang T, Hu Y, Sheng J, Wang J. Visuospatial Learning Selectively Enhanced by Personalized Transcranial Magnetic Stimulation over Parieto-Hippocampal Network among Patients at Clinical High-Risk for Psychosis. Schizophr Bull. 2023 Jul 4;49(4):923-932. doi: 10.1093/schbul/sbad015. PMID 36841956
  • Zhang T, Xu L, Wei Y, Cui H, Tang X, Hu Y, Tang Y, Wang Z, Liu H, Chen T, Li C, Wang J. Advancements and Future Directions in Prevention Based on Evaluation for Individuals With Clinical High Risk of Psychosis: Insights From the SHARP Study. Schizophr Bull. 2025 Mar 14;51(2):343-351. doi: 10.1093/schbul/sbae066. PMID 38741342

Identifiers

NCT: NCT06802952 · MEG-CHR-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗