NCT02863094

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Schizophrenia Patients With Auditory Hallucinations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To investigate the treatment effect of continuous transcranial magnetic stimulation on schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by functional MRI

Detailed description

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group by random number. There are about 30 patients in each group.The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing AVH and other measures. Each patient would be treated for continuous 15 days by rTMS Before the rTMS treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and the Positive and Negative Syndrome Scale were obtained by a trained investigator to assess baseline severity of auditory verbal hallucination (AVH) and other symptoms. The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and Iowa-gambling test record. After the last treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, and the Positive and Negative Syndrome Scale were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record. A month after the last treatment, participants were interviewed to obtain the Auditory Hallucination Rating Scale, Psychotic Symptom Rating Scale, the Positive, and Negative Syndrome Scale. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.

Conditions

• Schizophrenia
• Transcranial Magnetic Stimulation
• Functional Magnetic Resonance Imaging

Interventions

Type	Name	Description
DEVICE	transcranial magnetic stimulation

Timeline

• Start date: 2016-05-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2016-08-11
• Last updated: 2021-10-12

Locations

1 site across 1 country: China