RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

NCT06802952 | Recruiting DMC

• 1 other identifier: MEG-CHR-2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical High-risk Syndrome of Psychosis

Keywords

Clinical high-risk syndrome of psychosis; MEG; rTMS; Individualized targets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction rate of the PNASS scale

  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.

Study Arms (1)

Physical intervention for before-after study in the same subject with CHR

OTHER

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

Interventions

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.

Physical intervention for before-after study in the same subject with CHR

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Yegang Hu, Doctor

CONTACT

+86-21-52219305; yeganghu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory self controlled clinical intervention trial. 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.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CN (1)