rTMS for Auditory Hallucinations Guided by Magnetoencephalography

• Sponsor: Shanghai Mental Health Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05598450
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: rTMS and MEG for auditory hallucinations via single arm	N/A

Detailed Description

Before receiving rTMS treatment, patients should do multiple magnetoencephalograms (such as 3 times) to find the target. The patient opened his eyes and rested quietly while receiving 1Hz low frequency rTMS for 23 minutes. The 8-shaped coil corresponds to the result of magnetoencephalogram positioning by the electrode position. A total of one course of treatment (15-20 days) was intervened, and five follow-up visits were made respectively on the 7th, 14th, 30th, 60th and 90th days after the intervention.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: rTMS for Auditory Hallucinations Guided by Magnetoencephalography
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: schizophrenia patients with auditory hallucinations For schizophrenia patients with auditory hallucinations, rTMS+MEG for implementation intervention	Device: rTMS and MEG for auditory hallucinations via single arm; a 4 weeks, weekly 230 minutes, 1Hz, 100%RMT-rTMS protocol

Outcome Measures

Primary Outcome Measures

1. Reduction rate of AHRS scale [One month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mental Health Center	Shanghai		China	021

Sponsors and Collaborators

• Shanghai Mental Health Center

Investigators

• Principal Investigator: Yegang Hu, Doctor, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT05598450
• Other Study ID Numbers: NDYX20220601
• First Posted: Oct 28, 2022
• Last Update Posted: Oct 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hallucinations; Schizophrenia

Study Results

No Results Posted as of Oct 28, 2022