rTMS for Auditory Hallucinations Guided by Magnetoencephalography

NCT ID: NCT05598450

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

schizophrenia patients with auditory hallucinations

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

Group Type: EXPERIMENTAL

rTMS and MEG for auditory hallucinations via self controlled clinical trials

Intervention Type: DEVICE

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.

Interventions

rTMS and MEG for auditory hallucinations via self controlled clinical trials

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yegang Hu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yegang Hu, Doctor

Role: CONTACT

yeganghu@126.com

021-52219305

Facility Contacts

Yegang Hu, Doctor

Role: primary

yeganghu@126.com

021-52219305

References

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.

Reference Type: RESULT

PMID: 32800379 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36113473 (View on PubMed)

Other Identifiers

NDYX20220601

Identifier Type: -

Identifier Source: org_study_id