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Search / Trial NCT04798131

fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Launched by UNIVERSITY HOSPITAL, LILLE · Mar 11, 2021

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Schizophrenia Hallucinations Drug Resistance Functional Mri Neurofeedback Machine Learning.

ClinConnect Summary

The INTRUDE trial is studying a new treatment for people with schizophrenia who experience drug-resistant auditory hallucinations—these are sounds or voices that aren't real and can be very distressing. The researchers want to see if a special technique called fMRI-based neurofeedback can help these patients. This method uses real-time brain imaging to help patients learn how to change their brain activity and reduce the severity of their hallucinations. The trial will involve 86 participants, who will be divided into two groups: one will receive the active treatment while the other will receive a placebo (a fake treatment that looks the same) without knowing which one they're getting. Each patient will go through four sessions of feedback, and the researchers will measure how well their hallucinations improve.

To be eligible for the trial, participants need to have a diagnosis of schizophrenia, experience frequent auditory hallucinations, and be on stable medication for at least 30 days. They should not have any severe neurological disorders, be pregnant, or have issues with MRI scans, such as claustrophobia. If you or someone you know fits these criteria and is interested in participating, this trial could provide a new hope for managing challenging symptoms.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Schizophrenia (according to the DSM-5 classification)
  • Frequent auditory hallucinations (SAPS item #1 ≥ 4)
  • Stable medication for at least 30 days
  • Absence of chronic neurological disorder (including seizure)
  • Able to provide free written consent to participate in the research
  • Exclusion Criteria:
  • Pregnancy
  • Contraindication to MRI scan
  • Claustrophobia
  • No social insurance

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Patients applied

0 patients applied

Trial Officials

Renaud JARDRI, MD,PhD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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