RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

RTMS for Clinical High-risk Syndrome of Psychosis 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.

Study Overview

• Status: Recruiting
• Conditions: Clinical High-risk Syndrome of Psychosis
• Intervention / Treatment: Device: rTMS

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yegang Hu, Doctor; Phone Number: +86-21-52219305; Email: yeganghu@126.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Mental Health Center
    • Contact: Yegang Hu, Ph.D.; Phone Number: 86-21-5221 9305; Email: yeganghu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Physical intervention for before-after study in the same subject with CHR; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction rate of the SIPS/SOPS scale	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.	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

Outcome Measure	Measure Description	Time Frame
Reduction rate of the PNASS scale	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.	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.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Publications and helpful links

General 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.
• 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. 2024 May 14:sbae066. doi: 10.1093/schbul/sbae066. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: MEG; rTMS; Clinical high-risk syndrome of psychosis; Individualized targets
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Pathologic Processes; Disease; Psychotic Disorders; Syndrome; Mental Disorders
• Other Study ID Numbers: MEG-CHR-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All research data sharing related to humans requires hospital approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No