ClinicalTrials.gg
RecruitingNCT06802939Updated Feb 14, 2025

RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography

An interventional study of rTMS in Refractory Auditory Hallucinations and Schizophrenia, sponsored by Shanghai Mental Health Center. Recruiting at 1 site in China. Open to participants aged 13 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
13 Years to 55 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Refractory Auditory Hallucinations
  • Schizophrenia

Keywords

  • auditory hallucinations
  • rTMS
  • MEG
  • Individualized targets
03

In context

Hallucinations

136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.

This study's planned enrollment of 36 is below the median of 48 across 118 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of schizophrenia
  • Must be able to right-handed
  • Primary school education or above
  • Understand and sign a written 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • 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

Interventions

  • DevicerTMS

    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.

06

What researchers measure

Primary outcomes

  1. Reduction rate of the AHRS scale

    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.

    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.

Secondary outcomes

  1. Reduction rate of the PSYRATS scale

    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.

    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.

  2. 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.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Lynch CJ, Elbau IG, Ng TH, Wolk D, Zhu S, Ayaz A, Power JD, Zebley B, Gunning FM, Liston C. Automated optimization of TMS coil placement for personalized functional network engagement. Neuron. 2022 Oct 19;110(20):3263-3277.e4. doi: 10.1016/j.neuron.2022.08.012. Epub 2022 Sep 15. PubMed 36113473 ↗
  • Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7. PubMed 32800379 ↗

Individual participant data

Plan to share: Undecided — All research data sharing related to humans requires hospital approval.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06802939
Responsible party
Sponsor
First posted
Jan 31, 2025
Start date
Feb 5, 2025
Primary completion
Dec 10, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 14, 2025

Study contacts

Yegang Hu, Doctor
Contact
yeganghu@126.com
+86-21-52219305

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion