Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01512290
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2012-01-09
Brief Title:
Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations a Placebo-controlled Trail
Status:
COMPLETED
Status Verified Date:
2014-09
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:
Auditory verbal hallucinations AVH are a characterising symptom of schizophrenia In the majority of patients these AVH respond well to antipsychotic medication Yet a significant minority continues to experience frequent AVH despite optimal pharmacotherapy The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations Transcranial magnetic stimulation TMS in contrast is a non-invasive technique of influencing cortical excitability This technique has the potential to actually decrease the frequency and severity of medication resistant hallucinations
Several previous studies have assessed efficacy of low frequency rTMS with contradicting results A previous large study by the investigators group could not demonstrate efficacy of low frequency rTMS A new stimulation protocol using theta burst rTMS TBS could provide a more effective therapeutic option
Objective The present study aims to examine the efficacy of TBS on the severity of AVH Study design The objectives are tested in a randomized double blind placebo-controlled trail
Study population 60 patients with the diagnosis of schizophrenia schizoaffective disorder schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included
Intervention The participant will receive either 10 TBS treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area distributed over 5 treatment days Stimulation will be at 80 of the motor threshold
Main study parametersendpoints the main study parameter is the change in the severity of the AVH The secondary study parameter is the number and severity of adverse events
Several previous studies have assessed efficacy of low frequency rTMS with contradicting results A previous large study by the investigators group could not demonstrate efficacy of low frequency rTMS A new stimulation protocol using theta burst rTMS TBS could provide a more effective therapeutic option
Objective The present study aims to examine the efficacy of TBS on the severity of AVH Study design The objectives are tested in a randomized double blind placebo-controlled trail
Study population 60 patients with the diagnosis of schizophrenia schizoaffective disorder schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included
Intervention The participant will receive either 10 TBS treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area distributed over 5 treatment days Stimulation will be at 80 of the motor threshold
Main study parametersendpoints the main study parameter is the change in the severity of the AVH The secondary study parameter is the number and severity of adverse events
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