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NCT Number: NCT06802952

RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

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.

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Key information

Conditions

Clinical High-risk Syndrome of Psychosis

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study is divided into two parts:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device

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 outcomes

  1. 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.

    SIPS/SOPS (Structured Interview for Psychosis-Risk Syndromes/Scale of Psychosis-Risk Symptoms) is a scale used to assess subjects' structural interviews on prodromal symptoms of psychosis. The SIPS/SOPS scales, due to their inclusion of multiple assessment items with potentially varying scores for each, do not allow for a straightforward determination of an overall minimum and maximum value. A higher score indicates more severe symptoms in the assessed individual, while a lower score suggests less severe symptoms.

Secondary outcomes

  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.

    PNASS (Positive and Negative Syndrome Scale) is a scale for evaluating Psychiatric disorders. Each item is scored on a scale from 1 to 7, with 1 being the lowest score and 7 being the highest. Therefore, the minimum possible score on the PANSS is 30, and the maximum is 210. A higher score indicates more severe symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Yegang Hu, Doctor

CONTACT

[email protected]

+86-21-52219305

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.