RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

NCT ID: NCT06802952

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2026-12-31

Brief 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

Clinical High-risk Syndrome of Psychosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

rTMS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yegang Hu, Doctor

Role: CONTACT

yeganghu@126.com

+86-21-52219305

Facility Contacts

Yegang Hu, Ph.D.

Role: primary

yeganghu@126.com

86-21-5221 9305

References

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.

Reference Type: BACKGROUND

PMID: 36841956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38741342 (View on PubMed)

Other Identifiers

MEG-CHR-2024

Identifier Type: -

Identifier Source: org_study_id