Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01941251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2013-09-09
Brief Title:
Navigated αTMS in Treatment-resistant Schizophrenia
Sponsor:
Niuvanniemi Hospital
Organization:
Niuvanniemi Hospital
Study Overview
Official Title:
Navigated Alpha Frequency Transcranial Magnetic Stimulation αTMS in Treatment-resistant Schizophrenia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
nTMS_NS
Brief Summary:
Since 1990s stimulation of prefrontal cortex PFC has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia However previous studies have reported mixed or negative results Majority of the repetitive transcranial magnetic stimulation rTMS studies to date has set the target of cortical stimulation based on scalp site Recently introduced method navigated transcranial magnetic stimulation nTMS integrates the individual MRI data and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia Some recent studies using alpha α EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results
The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized double-blind sham-controlled study The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex DLPFC as adjunctive therapy for 3 weeks We assess patients via the Positive and Negative Syndrome Scale PANSS Clinical Global Impression CGI and neurocognitive test battery at baseline 5 days after and 3 months after treatment Serum and plasma levels of brain derived neurotrophic factor BDNF are assayed at pre and post treatment weeks
The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized double-blind sham-controlled study The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex DLPFC as adjunctive therapy for 3 weeks We assess patients via the Positive and Negative Syndrome Scale PANSS Clinical Global Impression CGI and neurocognitive test battery at baseline 5 days after and 3 months after treatment Serum and plasma levels of brain derived neurotrophic factor BDNF are assayed at pre and post treatment weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None