Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004980
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2000-03-10
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Voices
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear Voices
Status:
COMPLETED
Status Verified Date:
2013-08
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:
OBJECTIVES
I Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia
I Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind study Patients are randomized to one of two treatment arms
Group I Patients receive 9 sessions of active transcranial magnetic stimulation rTMS which consists of 8 minutes of rTMS during session 1 12 minutes duration during session 2 and 16 minutes duration during sessions 3-9 The total duration of stimulation is 132 minutes Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends
Group II Patients receive 9 sessions of sham stimulation which consists of 8 minutes of sham stimulation during session 1 12 minutes duration sham stimulation during session 2 and 16 minutes duration sham stimulation during sessions 3-9 The total duration of sham stimulation is 132 minutes Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
Group I Patients receive 9 sessions of active transcranial magnetic stimulation rTMS which consists of 8 minutes of rTMS during session 1 12 minutes duration during session 2 and 16 minutes duration during sessions 3-9 The total duration of stimulation is 132 minutes Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends
Group II Patients receive 9 sessions of sham stimulation which consists of 8 minutes of sham stimulation during session 1 12 minutes duration sham stimulation during session 2 and 16 minutes duration sham stimulation during sessions 3-9 The total duration of sham stimulation is 132 minutes Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A5-ETPD | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH063326 |
| R21MH063326 | NIH | None | None |
| YALESM-9281 | None | None | None |
| 19914809 | None | None | None |