Clinical trial NCT05598450: rTMS for Auditory Hallucinations Guided by Magnetoencephalography
Official title: rTMS for Auditory Hallucinations Guided by Magnetoencephalography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction rate of AHRS scale
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Yegang Hu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.