DecNef for AVH in Schizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNew York State Psychiatric Institute
About this trial
The purpose of this study is to learn whether a research neurofeedback training approach done during MRI scans may help reduce hallucinations such as the experience of hearing voices persistent despite treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 to 55, inclusive at screen
Capable of understanding the study procedures and willing and able to provide informed consent
Diagnosed with schizophrenia or schizoaffective disorder
Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.
Disqualifiers
Diagnosis of moderate or severe substance use disorder (excluding nicotine) within the previous 90 days
Positive toxicology screen for any substances of abuse
Participation in study of investigational medication/device within the past 4 weeks
Pregnant persons. Persons of child-bearing potential must have a negative urine β-hCG pregnancy test at Visit 1 and Visit 1a (if applicable)
Trial design
Design model
Parallel
Treatments tested in this trial
Decoded Neurofeedback
DeviceIn this study participants will be randomly assigned to either active or control decoded neurofeedback.
Treatment groups
51 Participants
are divided into 2 treatment groupsGroup A: Active Decoded NeurofeedbackExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Target Engagement
Target engagement will be evaluated by assessing how closely a participant's brain activity aligns with the desired activation pattern as determined by the fMRI decoder.
Time frame
During MRI sessions (from randomization through final MRI scan).2
Auditory Hallucination Rating Scale
The Auditory Hallucination Rating Scale (AHRS) will be the primary tool to evaluate auditory verbal hallucinations.
Time frame
During assessment administration (from randomization through final MRI scan)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: