SchizophreniaINTRUDENCT04798131
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
A study testing Active neurofeedback procedure in people with Schizophrenia and Hallucinations, Auditory, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Hallucinations, Auditory, Hallucinations, Visual
- What is being tested?
- Active neurofeedback procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2022to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Right-handed female/male between 18 to 60 y.o.
- 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
Who cannot join
- Refusal to participate after clear and honest information about the study has been provided
- Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia)
- Pregnancy
- Contraindication to MRI scan: pacemaker, ferromagnetic vascular clip, ferromagnetic foreign body
- Morphological criteria: weight >130kg, abdominal cirumference exceeding magnet aperture, shoulder width
- Claustrophobia
- Refusal to be informed of any incidental findings observed during the MRNI
- No social insurance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
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 (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 12 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 and re-evaluated at 2 months post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.
- Being tested
- Active neurofeedback procedure, Sham neurofeedback procedure
- Keywords
- Schizophrenia, Hallucinations, Drug-resistance, functional MRI, Neurofeedback, Machine-Learning.
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active neurofeedback procedureOther
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will continuously receive visual feedback (12 runs in total) computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. Two post-treatment visits are scheduled at 1 and 2 months to assess hallucinations severity.
Sham neurofeedback procedureOther
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will receive a random feedback (12 runs in total). Two post-treatment visits are scheduled at 1 and 2 months with the same clinical assessment than the active group.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | The visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal. Receives: Other: Active neurofeedback procedure |
| Sham | Sham comparator | The visual feedback will correspond to random instructions independently of the fMRI signal. Receives: Other: Sham neurofeedback procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
AHRS will be measured at t0 (randomization) and at 1 month after treatment Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms.
Measured: 1 month after treatment
Secondary outcomes (6)
Change from baseline in Auditory Hallucinations Rating Scale (AHRS) measure
AHRS will be measured at t0 (randomization) and at 1 month after treatment The PANSS contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. rate from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210
Measured: 1 month and 2 months after treatment
Changes in global functioning relative to baseline
Global Assessment of Functioning (GAF) is a numeric scale be measured at t0 (randomization) and at 1 month after treatment Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Measured: 1 month and 2 months after treatment
Changes in quality of life relative to baseline
SQLS score will be measured at t0 (randomization) and at 1 month after treatment
Measured: 1 month and 2 months after treatment
Changes in structural MRI markers relative to baseline
Cortical thickness will be measured at t0 (randomization) and at 1 month after treatment
Measured: 1 month and 2 months after treatment
Changes in structural MRI markers relative to baseline
Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment
Measured: 1 month and 2 months after treatment
Changes in functional MRI markers relative to baseline
Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start26 Aug 2022
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Renaud JARDRI, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798131
- Sponsor's protocol ID
- 2020_08
- Other IDs
- 2020-A00631-38, WP3 UNREHAL
- Acronym
- INTRUDE
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04798131
- Acronym / sponsor ID
- INTRUDE / 2020_08
- Keywords
- Schizophrenia, Hallucinations, Drug-resistance, functional MRI, Neurofeedback, Machine-Learning.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 12 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 and re-evaluated at 2 months post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Active neurofeedback procedureThe visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal. |
| Sham | Sham comparator | Other: Sham neurofeedback procedureThe visual feedback will correspond to random instructions independently of the fMRI signal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Right-handed female/male between 18 to 60 y.o.
- 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)
Key exclusion criteria (8 listed)
- Refusal to participate after clear and honest information about the study has been provided
- Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia)
- Pregnancy
- Contraindication to MRI scan: pacemaker, ferromagnetic vascular clip, ferromagnetic foreign body
- Morphological criteria: weight >130kg, abdominal cirumference exceeding magnet aperture, shoulder width
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active neurofeedback procedurePatients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will continuously receive visual feedback (12 runs in total) computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. Two post-treatment visits are scheduled at 1 and 2 months to assess hallucinations severity. | Other | Active |
| Sham neurofeedback procedurePatients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will receive a random feedback (12 runs in total). Two post-treatment visits are scheduled at 1 and 2 months with the same clinical assessment than the active group. | Other | Sham |
Primary outcome
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
Time frame: 1 month after treatment
AHRS will be measured at t0 (randomization) and at 1 month after treatment Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms.
6 secondary outcomes
Change from baseline in Auditory Hallucinations Rating Scale (AHRS) measure
Time frame: 1 month and 2 months after treatment
Changes in global functioning relative to baseline
Time frame: 1 month and 2 months after treatment
Changes in quality of life relative to baseline
Time frame: 1 month and 2 months after treatment
Changes in structural MRI markers relative to baseline
Time frame: 1 month and 2 months after treatment
Changes in structural MRI markers relative to baseline
Time frame: 1 month and 2 months after treatment
Changes in functional MRI markers relative to baseline
Time frame: 1 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renaud JARDRI, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active neurofeedback procedure in people with Schizophrenia and Hallucinations, Auditory, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud JARDRI, MD,PhD (0320445962 ext. +33, renaud.jardri@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity (time frame: 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.