RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography

February 12, 2025 updated by: Shanghai Mental Health Center
This study is an before-after study in the same patient, which enrolled 36 psychiatric patients with refractory auditory hallucinations. The target of patient intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period. The investigators assume that the intervention targets for each auditory hallucination patient are individualized.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is divided into two parts:

  1. Target determination. Firstly, MEG data of the patient's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the patient's abnormal signals in the brain, which is then used as the intervention target. Based on the patient'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 auditory hallucinations in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia
  • 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)
  • Existence of persistent auditory hallucinations (defined as: taking sufficient antipsychotic medication for at least 6 months, combined with 3 antipsychotic medications still ineffective, and no significant improvement in auditory hallucinations symptoms, with an AHRS score still>12)

Exclusion Criteria:

  • MECT treatment within the past 3 months
  • 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)
  • Aggressive behavior and an impulse to damage equipment
  • Metal (including orthodontic treatment, dental implants) and tattoos inside the body
  • Claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physical intervention for before-after study in the same patient with auditory hallucinations
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 AHRS 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.
AHRS (Auditory Hallucinations Rating Scale) is a scale used to assess patients' auditory hallucinations within the past 24 hours. The minimum score of the AHRS scale is 0, indicating the absence of auditory hallucination symptoms, while the maximum score represents the most severe level of symptoms. The specific numerical values need to refer to the version of the scale being used.
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
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.
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.
Reduction rate of the PSYRATS 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.
PSYRATS(Psychotic Symptom Rating Scales) is a scale used to assess patients' auditory hallucinations within the past week. The PSYRATS scale is a semi-structured interview scale designed for assessing the multidimensional symptoms of auditory hallucinations and delusions, consisting of 17 items. The scale is scored on a 0-4 rating scale, with detailed explanations for each rating level, and is administered by trained staff to evaluate patients. Theoretically, the minimum score of the PSYRATS scale is 0 (when all items are scored 0), while the maximum score is 68 (when all items are scored 4). 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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Estimated)

December 10, 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 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEG-AHTM-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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