Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04012684
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2019-07-07
Brief Title:
rTMS on Mismatch Negativity of Schizophrenia
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Using Repetitive Transcranial Magnetic Stimulation to Improve the Auditory Mismatch Negativity Deficits of Schizophrenia a Randomized Double-blinded Sham-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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 mismatch negativity deficit is a robust neurophysiological biomarker of schizophrenia Repetitive transcranial magnetic stimulation rTMS is a neuromodulation method and can be used to modulate excitability of specific brain cortical region We hypothesize that MMN deficit of schizophrenia is related to inferior frontal gyrus IFG hypofunction and this deficit can be improved by using rTMS to enhance IFG function
It is a randomized double-blinded sham-controlled clinical trial Forty-eight schizophrenia patients with MMN deficits mean amplitude at FCz -07 will be recruited and then randomized at a 11 ratio to rTMS group and sham-stimulation group Subjects in rTMS group will receive high frequency rTMS over IFG while in the other group subjects will receive sham stimulation at IFG Frameless stereotaxy navigation will be used to guide the rTMS coil to IFG The primary outcome is the change of MMN mean amplitude at FCz after stimulation We hypothesize that the change of MMN mean amplitude is significantly larger in rTMS group than in sham-stimulation group Their cognitive function and clinical condition will be evaluated carefully before and after experiments
It is a randomized double-blinded sham-controlled clinical trial Forty-eight schizophrenia patients with MMN deficits mean amplitude at FCz -07 will be recruited and then randomized at a 11 ratio to rTMS group and sham-stimulation group Subjects in rTMS group will receive high frequency rTMS over IFG while in the other group subjects will receive sham stimulation at IFG Frameless stereotaxy navigation will be used to guide the rTMS coil to IFG The primary outcome is the change of MMN mean amplitude at FCz after stimulation We hypothesize that the change of MMN mean amplitude is significantly larger in rTMS group than in sham-stimulation group Their cognitive function and clinical condition will be evaluated carefully before and after experiments
Detailed Description:
None
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?:
None