Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798131
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-25
First Post:
2021-01-14
Brief Title:
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback a Randomized-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-03
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:
INTRUDE
Brief Summary:
The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder Based on this progress we can track patients hallucinatory status using real-time fMRI We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity We will refer to a double-blind randomized placebo-controlled design A total of 86 patients will be enrolled and equally split in an active neurofeedback group n43 and a sham group n43 matched for sex age and PANSS scores Each patient will benefit from 4 runs of either active or sham neurofeedback The primary outcome measure will be the mean decrease of AHRS scores relative to baseline and at 1 month post-treatment We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A00631-38 | OTHER | None | None |
| ANR-16-CE37-0015 | OTHER | ANR number | None |