Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02744989
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2016-03-18
Brief Title:
STIMZO Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
STIMZO Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia SCH
Status:
COMPLETED
Status Verified Date:
2022-10
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:
STIMZO
Brief Summary:
This project aims to provide the proof of concept for transcranial direct-current stimulation tDCS in the treatment of resistantpersistent Schizophrenia symptoms The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication An early optimization of the therapeutic strategy must constitute an important factor for prognosis Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics In this study stimulation is an add-on treatment to antipsychotic medication and will be used in a broad variety of patients ie in patients with varied durations of illness various symptoms profiles and various levels of treatment response This in turn will allow the determination of the extent to which results can be generalized to varied patient populations as well as the extent to which various therapeutic targets eg different symptom dimensions cognitive performance and brain connectivity may be improved with tDCS Despite interesting preliminary results our team is unable to describe optimal non-invasive brain stimulation NIBS response markers
This study is a randomized double blind controlled French multicenter study 11 centers The investigators plan to include 144 patients with persistent symptoms in schizophrenia Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS placebo Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders defined as a decrease of at least 25 of symptoms as measured by a standardized clinical scale score PANSS between baseline and after the 10-session tDCS regimen
Furthermore the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers An analysis of the effects on cortical activity and plasticity markers could be an interesting approach
This study is a randomized double blind controlled French multicenter study 11 centers The investigators plan to include 144 patients with persistent symptoms in schizophrenia Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS placebo Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders defined as a decrease of at least 25 of symptoms as measured by a standardized clinical scale score PANSS between baseline and after the 10-session tDCS regimen
Furthermore the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers An analysis of the effects on cortical activity and plasticity markers could be an interesting approach
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