Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168311
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2005-09-14
Brief Title:
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation rTMS in the Treatment of Negative Symptoms in Schizophrenia
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation rTMS in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders
Status:
COMPLETED
Status Verified Date:
2012-04
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:
rTMS
Brief Summary:
There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal cortex in the treatment of negative symptoms Neuroimaging studies demonstrate abnormal activity in this region in patients experiencing negative symptoms Finally rTMS applied at high frequency shows the capacity to up-regulate cortical activity in a way that would provide an explanation for a therapeutic response
The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS Following this double blind phase participants randomised to placebo treatment will be offered 15 sessions of active treatment
In addition ppTMS paired pulse TMS will be conducted prior to the onset of treatment and after completion of the course as a means of measuring cortical inhibition and facilitation NIRS Near Infra red spectroscopy will also be conducted prior to during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin
The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS Following this double blind phase participants randomised to placebo treatment will be offered 15 sessions of active treatment
In addition ppTMS paired pulse TMS will be conducted prior to the onset of treatment and after completion of the course as a means of measuring cortical inhibition and facilitation NIRS Near Infra red spectroscopy will also be conducted prior to during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin
Detailed Description:
The main outcome measure used is the SANS Scale for the Assessment of Negative Symptoms This is a semi strucutured interview which provides scores from 0-70 This is administered at baseline week 2 3 5 and 6
Other outcome measures administered are frequency mentioned above PANSS Positive and Negative Syndrome Scale and the Calgery Depression Scale for Schizophrenia A cognitive battery is also administered
Inclusion Criteria
Diagnostic and Statistical Manual-IV diagnosis of schizophrenia or schizoaffective disorder age over 18
Persistent negative symptoms of moderate to severe intensity
Failure to respond to a minimum of two antipsychotic medications
No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial Exclusion Criteria
Prominent positive symptoms
Have an unstable medical condition neurological disorder or any history of seizure disorder or are currently pregnant or lactating
Previous brain injury or surgery any metal clips plates or other metal items in the head cardiac pacemaker
Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
Substance dependence
Other outcome measures administered are frequency mentioned above PANSS Positive and Negative Syndrome Scale and the Calgery Depression Scale for Schizophrenia A cognitive battery is also administered
Inclusion Criteria
Diagnostic and Statistical Manual-IV diagnosis of schizophrenia or schizoaffective disorder age over 18
Persistent negative symptoms of moderate to severe intensity
Failure to respond to a minimum of two antipsychotic medications
No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial Exclusion Criteria
Prominent positive symptoms
Have an unstable medical condition neurological disorder or any history of seizure disorder or are currently pregnant or lactating
Previous brain injury or surgery any metal clips plates or other metal items in the head cardiac pacemaker
Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
Substance dependence
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