Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 10:40 PM
Study NCT ID:
NCT03868358
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2019-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
Sponsor:
WANG KAI
Organization:
Study Overview
Official Title:
Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram
Detailed Description:
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after intermittent theta-burst transcranial magnetic stimulation (iTBS) treatment. Patients were randomly allocated to iTBS group and the sham group by coin toss. 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 iTBS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Positive and Negative Syndrome Scale (PANSS). Each patient would be treated for continuous 14 days by iTBS.Before the iTBS treatment, PANSS and Clinical Global Impression-severity of illness (CGI-SI) at baseline were obtained by a trained investigator to assess baseline severity of their symptoms. Scale for the Assessment of Negative Symptoms (SANS) and Scale for Assessment of Positive Symptoms (SAPS) were respectively supplemented to evaluate the severity of symptoms in different dimensions,.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. Other behavioral tests including intertemporal decision,spatial n-back test record.
After the last treatment, 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 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI), Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.
40-60 days after the last treatment, participants were interviewed to obtain the Positive and Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. 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.
After the last treatment, 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 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI), Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.
40-60 days after the last treatment, participants were interviewed to obtain the Positive and Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: