Actively Recruiting

Phase Not Applicable
Age: 13Years - 35Years
All Genders
ID06802952

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

Led by Shanghai Mental Health Center · Updated on 2025-02-11

26

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a treatment for individuals aged 13 to 35 with Clinical High-risk Syndrome of Psychosis (CHR). The study aims to explore personalized brain stimulation targets identified using magnetoencephalography (MEG) to better understand and treat abnormal brain signals related to this condition. Participants have either not started antipsychotic medication or maintain stable medication and dosage during the study. The approach is individualized based on each person's brain activity. The study is divided into two parts. First, MEG scans locate abnormal brain signals during rest and task states to determine 2 to 4 specific targets for intervention. Second, participants receive repetitive transcranial magnetic stimulation (rTMS) at these personalized targets. The rTMS involves low-frequency 1Hz stimulation, with 1400 pulses per session at 100% exercise threshold, each lasting 23 minutes. The treatment starts with 10 days of pseudo stimulation over 2 weeks, followed by a 2-week rest, then 10 days of real stimulation over weeks 3 and 4. Rest periods of 30 to 60 minutes occur between targeting sessions. Participants undergo scale evaluations before and after pseudo and real stimulation phases, with follow-up visits at 7, 14, 30, 60, and 90 days after treatment ends. Researchers measure the reduction rates on clinical assessment scales such as SIPS/SOPS and PNASS to evaluate changes. The study includes detailed monitoring of symptoms and brain responses to develop individualized treatment plans for CHR in clinical practice.

CONDITIONS

Brief Title

RTMS for CHR Based on Personalized Targets Using Magnetoencephalography

Who Can Participate

Age: 13Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Clinical High-Risk Syndrome for Psychosis
  • Must be right-handed
  • Completed primary school education or above
  • Understand and sign written informed consent (guardian consent required if under 18 years old)
Not Eligible

You will not qualify if you...

  • Major physical illnesses such as sensory and motor disorders, neurological disorders, or traumatic brain injury
  • Conditions that prevent rTMS treatment like intracranial metal implants
  • Presence of metal in the body including orthodontic devices, dental implants, or tattoos inside the body
  • Claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Target Determination

Duration - Up to 2 weeks

Participants undergo magnetoencephalography (MEG) to collect resting and task state data and identify precise brain targets for intervention based on abnormal brain signals.

1 to 2 visits depending on data collection

Treatment

Duration - 6 weeks total including rest

Participants receive a pseudo stimulation intervention using low-frequency rTMS for 10 days over 2 weeks, followed by a 2-week rest period, then 10 days of real rTMS stimulation over 2 weeks targeting 2-4 brain areas per session.

5 visits per week during intervention weeks for a total of 20 visits

Follow-up

Duration - 3 months

Participants have follow-up evaluations to assess treatment effects on days 7, 14, 30, 60, and 90 after the intervention ends.

5 follow-up visits

Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, China, 200030

Actively Recruiting

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Research Team

Y

Yegang Hu, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Visuospatial Learning Selectively Enhanced by Personalized Transcranial Magnetic Stimulation over Parieto-Hippocampal Network among Patients at Clinical High-Risk for Psychosis.

Yingying Tang, Lihua Xu, Tianyuan Zhu...

https://pubmed.ncbi.nlm.nih.gov/36841956

Advancements and Future Directions in Prevention Based on Evaluation for Individuals With Clinical High Risk of Psychosis: Insights From the SHARP Study.

TianHong Zhang, LiHua Xu, YanYan Wei...

https://pubmed.ncbi.nlm.nih.gov/38741342