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rTMS for Auditory Hallucinations Guided by Magnetoencephalography

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS and MEG for auditory hallucinations via single arm
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

schizophrenia patients with auditory hallucinations

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
October 25, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05598450
Brief Title
rTMS for Auditory Hallucinations Guided by Magnetoencephalography
Official Title
rTMS for Auditory Hallucinations Guided by Magnetoencephalography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
schizophrenia patients with auditory hallucinations
Arm Type
Experimental
Arm Description
For schizophrenia patients with auditory hallucinations, rTMS+MEG for implementation intervention
Intervention Type
Device
Intervention Name(s)
rTMS and MEG for auditory hallucinations via single arm
Intervention Description
a 4 weeks, weekly 230 minutes, 1Hz, 100%RMT-rTMS protocol
Primary Outcome Measure Information:
Title
Reduction rate of AHRS scale
Description
Reduction rate of AHRS scale (the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yegang Hu, Doctor
Phone
021-52219305
Email
yeganghu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yegang Hu, Doctor
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yegang Hu, Doctor
Phone
021-52219305
Email
yeganghu@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32800379
Citation
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.
Results Reference
result
PubMed Identifier
36113473
Citation
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.
Results Reference
result

Learn more about this trial

rTMS for Auditory Hallucinations Guided by Magnetoencephalography

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