Clinical trial NCT06802939: RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography
Official title: RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Auditory Hallucinations
Schizophrenia
Keywords: auditory hallucinations
rTMS
MEG
Individualized targets
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 36
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory self controlled clinical intervention trial. Pseudo stimulus intervention in weeks 1-2, for a total of 10 days. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days.
Primary purpose: TREATMENT

Brief summary: This study is an before-after study in the same patient, which enrolled 36 psychiatric patients with refractory auditory hallucinations. The target of patient intervention relies on the results of magnetoencephalography localization. The medication and dosage remain unchanged during the intervention period. The investigators assume that the intervention targets for each auditory hallucination patient are individualized.

Detailed description: This study is divided into two parts:

1. Target determination. Firstly, MEG data of the patient's resting and task states are collected, and a precise localization model using magnetoencephalography is applied to locate the precise location of the patient's abnormal signals in the brain, which is then used as the intervention target. Based on the patient's tolerance for single day intervention, the appropriate number of targets is generally 2-4. The upper limit of targets is 4.
2. RTMS individualized intervention. Application of rTMS for 1Hz low-frequency intervention, with intervention parameters of 1400 sessions, 100% exercise threshold, and a total of 23 minutes per session. After each target intervention, rest for half an hour to one hour. The pseudo stimulation intervention lasted for 10 days in the first and second weeks, and the scale was evaluated after the end of the pseudo stimulation. After resting for 2 weeks, enter the 3-4 weeks of real stimulation, with 5 days of intervention per week for a total of 10 days. 2-4 targets per day, 23 minutes per target, with 30-60 minutes between interventions for each target. After the fourth week, evaluate the scale. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th day after intervention. By analyzing and evaluating data, explore individualized treatment plans for auditory hallucinations in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Must be able to right-handed
* Primary school education or above
* Understand and sign a written informed consent form (jointly signed by the guardian and the participant if under 18 years old)
* Existence of persistent auditory hallucinations (defined as: taking sufficient antipsychotic medication for at least 6 months, combined with 3 antipsychotic medications still ineffective, and no significant improvement in auditory hallucinations symptoms, with an AHRS score still\>12)

Exclusion Criteria:

* MECT treatment within the past 3 months
* Major physical illnesses (organic lesions such as sensory and motor disorders, neurological disorders, and traumatic brain injury)
* Taboo symptoms for rTMS treatment (such as intracranial metal implants)
* Aggressive behavior and an impulse to damage equipment
* Metal (including orthodontic treatment, dental implants) and tattoos inside the body
* Claustrophobia

Primary outcomes:
measure: Reduction rate of the AHRS scale
timeFrame: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.
Secondary outcomes:
measure: Reduction rate of the PSYRATS scale
timeFrame: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.
measure: Reduction rate of the PNASS scale
timeFrame: From enrolment to the end of the 2-week pseudostimulation treatment. From 2 weeks rest after the end of pseudostimulation treatment to the end of 2 weeks of true stimulation treatment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References:
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.
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.