Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361160
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Sponsor:
Centre Hospitalier St Anne
Organization:
Centre Hospitalier St Anne
Study Overview
Official Title:
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation Towards a Closed-loop System
Status:
RECRUITING
Status Verified Date:
2024-07
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:
HALLUSTIM
Brief Summary:
Approximately 1 of the general population will be affected by schizophrenia over the course of their lives with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease amongst which many will suffer from auditory-verbal hallucinations AVH that current therapeutic approaches struggle to alleviate Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Brocas area which would detect AVH in real time and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them The aim of this project is to assess the feasibility of this system To do so we will first test the ability of transcranial magnetic stimulation of the continuous theta burst cTBS type applied at the time of AVH onset to reduce their duration and intensity and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system
The research project comprises two phases
-Phase 1 randomized controlled clinical trial 1 weekly session per patient over 12 weeks 6 active stimulation sessions and 6 sham sessions evaluating the phasic effects of rTMS on AVHs as they appear during the sessions
Phase 2 open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH 10 TMS sessions over one workweek - twice daily with 1-hour intervals MULTIMODHAL study NCT01373866
The research project comprises two phases
-Phase 1 randomized controlled clinical trial 1 weekly session per patient over 12 weeks 6 active stimulation sessions and 6 sham sessions evaluating the phasic effects of rTMS on AVHs as they appear during the sessions
Phase 2 open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH 10 TMS sessions over one workweek - twice daily with 1-hour intervals MULTIMODHAL study NCT01373866
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