RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography

NCT06802939 | Recruiting DMC

• 1 other identifier: MEG-AHTM-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Auditory Hallucinations; Schizophrenia

Keywords

auditory hallucinations; rTMS; MEG; Individualized targets

Outcome Measures

Primary Outcomes (1)

• Reduction rate of the AHRS scale

  AHRS (Auditory Hallucinations Rating Scale) is a scale used to assess patients' auditory hallucinations within the past 24 hours. The minimum score of the AHRS scale is 0, indicating the absence of auditory hallucination symptoms, while the maximum score represents the most severe level of symptoms. The specific numerical values need to refer to the version of the scale being used.

  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 (2)

• Reduction rate of the PSYRATS scale

  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.

• Reduction rate of the PNASS scale

  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.

Study Arms (1)

Physical intervention for before-after study in the same patient with auditory hallucinations

OTHER

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.

Device: rTMS

Interventions

rTMS DEVICE

RTMS using 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. 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.

Physical intervention for before-after study in the same patient with auditory hallucinations

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 36113473 BACKGROUND

• 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.

  PMID: 32800379 BACKGROUND

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Yegang Hu, Doctor

CONTACT

+86-21-52219305; yeganghu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-12

Locations

CN (1)