Op fMRI gebaseerde neurofeedback om medicijnresistente auditieve hallucinaties te verlichten (INTRUDE)
Behandel refractaire auditieve hallucinaties bij schizofreniepatiënten met fMRI-geleide neurofeedback: een gerandomiseerde gecontroleerde studie
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Renaud JARDRI, MD,PhD
- Telefoonnummer: +33 0320445962
- E-mail: renaud.jardri@chru-lille.fr
Studie Locaties
-
-
-
Lille, Frankrijk
- Werving
- Hop Fontan Chu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Active
The visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal. |
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-vergelijker: Sham
The visual feedback will correspond to random instructions independently of the fMRI signal. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
Tijdsspanne: 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. |
1 month after treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in Auditory Hallucinations Rating Scale (AHRS) measure
Tijdsspanne: 1 month and 2 months after treatment
|
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 |
1 month and 2 months after treatment
|
|
Changes in global functioning relative to baseline
Tijdsspanne: 1 month and 2 months after treatment
|
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). |
1 month and 2 months after treatment
|
|
Changes in quality of life relative to baseline
Tijdsspanne: 1 month and 2 months after treatment
|
SQLS score will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
|
|
Changes in structural MRI markers relative to baseline
Tijdsspanne: 1 month and 2 months after treatment
|
Cortical thickness will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
|
|
Changes in structural MRI markers relative to baseline
Tijdsspanne: 1 month and 2 months after treatment
|
Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment |
1 month and 2 months after treatment
|
|
Changes in functional MRI markers relative to baseline
Tijdsspanne: 1 month after treatment
|
Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment |
1 month after treatment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Renaud JARDRI, MD,PhD, University Hospital, Lille
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020_08
- 2020-A00631-38 (Andere identificatie: ID-RCB number,ANSM)
- WP3 UNREHAL (Andere identificatie: PEPR PROPSY)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .