NCT05598450

Brief Summary

rTMS and MEG for auditory hallucinations via self controlled clinical trials. Repetitive transcranial magnetic stimulation (rTMS) can increase or decrease cortical excitability in patients with psychosis (such as schizophrenia). Here, we conducted an open clinical trial on 60 schizophrenics with auditory hallucinations. We searched for targets through magnetoencephalography and then intervened to prove that rTMS guided by magnetoencephalography is effective for auditory hallucinations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 18, 2024

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

October 25, 2022

Last Update Submit

April 16, 2024

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Reduction rate of AHRS scale

    Reduction rate of AHRS scale (the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)

    One month

Study Arms (1)

schizophrenia patients with auditory hallucinations

EXPERIMENTAL

For schizophrenia patients with auditory hallucinations, rTMS+MEG for implementation intervention

Device: rTMS and MEG for auditory hallucinations via self controlled clinical trials

Interventions

rTMS and MEG for auditory hallucinations via self controlled clinical trialsDEVICE

a 4 weeks, weekly 345（23min\*3times\*5day） minutes, 1Hz, 100%RMT-rTMS protocol Detail precedure: Before intervention, each patient was scheduled to collect three magnetoencephalogram data sessions. Apply MEG technology to calculate possible locations and determine three intervention targets. Pseudo stimulation in the first week, 5-day intervention, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. Evaluate the scale after the first week of pseudo stimulation. Week 2-4 real stimulation, intervention 5 days a week, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. After the end of the fourth week, evaluate the scale. And follow-up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th days after the intervention.

schizophrenia patients with auditory hallucinations

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS \>12, Take sufficient antipsychotics for at least 1 month.

You may not qualify if:

  • current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 021, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32800379RESULT

  • 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.

    PMID: 36113473RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic StimulationMagnetoencephalography

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsDiagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Officials

  • Yegang Hu, Doctor

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yegang Hu, Doctor

CONTACT

021-52219305yeganghu@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

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

July 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 18, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)