Auditory Control Enhancement (ACE) in Schizophrenia

Stopped early · Not applicable · Has a placebo group

Conditions studied: Auditory Hallucinations

In brief

The purpose of this clinical trial is to investigate neural markers of target engagement to further develop auditory control enhancement (ACE) as a novel, inexpensive, and noninvasive intervention to address treatment-refractory auditory hallucinations. Here, we will address questions about the feasibility and acceptability of ACE, as well as the degree to which ACE results in measurable engagement of biophysical and neurophysiological targets. Participants will complete: * Auditory Control Enhancement (ACE): Participants will be assigned by chance (such as a coin flip) into one of two groups to receive a different dosage or level of transcranial direct current stimulation (tDCS) during three sessions of cognitive training. tDCS is used to stimulate the brain for a short period of time. For tDCS one or two thin wet sponges are placed on the head and/or upper arm. The sponges will be connected to electrodes which will deliver a very weak electrical current. The Neuroelectrics Starstim 32 will be used to deliver tDCS. * Interviews: Before and after ACE, in two separate sessions, participants will be asked questions about a) background; b) functioning in daily life and across different phases of your life and past, present and future medical records. * Cognitive Tests: During the interview sessions, participants will also perform cognitive tests. Participants will be asked to complete computerized and pen-and-paper tests of attention, concentration, reading, and problem-solving ability. * EEG scan: Participants will be asked to complete EEG (electroencephalography) studies before and after ACE training. EEG will be measured using the same Neuroelectrics Starstim 32 system used for tDCS. EEG measures the natural activity of the brain using small sensors placed on the scalp. These sensors use conductive gel to provide a connection suitable for recording brain activity. During EEG, participants will watch a silent video while sounds are played over headphones, or sometimes count the sounds. In addition to these auditory tasks, participants will also be asked to perform visual attention tasks, such pressing a button for a letter or image. * Magnetic Resonance Imaging (MRI) Scan: Participants will also be asked to complete MRI studies before and after ACE training. An MRI is a type of brain scan that takes pictures of the brain that will later be used to create a 3D model of the brain. The MRI does not use radiation, but rather radio waves, a large magnet and a computer to create the images. Researchers will compare individuals receiving ACE to those receiving sham tDCS during cognitive training to determine effects of ACE.

Key facts

Study ID: NCT06155695
Run by: Brian A Coffman, PhD
People needed: 12
Starts: 2023-09-05
Expected to finish: 2024-12-18
Last updated by the study team: 2026-04-07

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Between the ages of 18-40
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis not otherwise specified (NOS), Affective Psychosis with mood incongruent hallucinations.
ability to provide informed consent
Intelligence quotient (IQ) >= 70, as measured by the Weschler Abbreviated Scale of Intelligence (WASI)
<5 years since the onset of first psychotic episode
persistent auditory hallucinations without remission despite attempting >2 antipsychotic medications and having > 1 month of medication compliance

You may not qualify if…

hearing deficit as assessed by audiometry (hearing threshold > 30 decibels (dB) nHL)
standard MRI contraindications (e.g. cardiac pacemaker, aneurysm clip, cochlear implants, history of metal fragments in body, neurostimulators, weight of 300 lbs. or more, or claustrophobia)
[self report] head injury with loss of conscious > 10 min, medical illness affecting brain function or structure, significant neurologic disorder (e.g. seizure disorder),
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder - other than cannabis - and except individuals who have met at least early remission criteria (3 months without dependence symptoms) or a psychotic illness with a temporal relation to a substance use disorder
currently pregnant or early postpartum (<6 weeks after delivery or miscarriage)
currently taking medications that affect alertness, other than antipsychotic medication (e.g. sedatives, tranquilizers, muscle relaxants, and sleeping aids)

Where it is running

Western Psychiatric Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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