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Behavioural Intervention

ACE for Schizophrenia (ACES Trial)

N/A
Recruiting
Research Sponsored by Brian A Coffman, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis NOS, Affective Psychosis with mood incongruent hallucinations
Persistent auditory hallucinations without remission despite attempting >2 antipsychotic medications and having > 1 month of medication compliance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3 minus week 1
Awards & highlights

ACES Trial Summary

This trial will study the effects of a non-invasive, inexpensive intervention (ACE) on auditory hallucinations in order to measure engagement of biophysical & neurophysiological targets using cognitive tests, interviews, EEG & MRI scans.

Who is the study for?
This trial is for individuals aged 18-40 with schizophrenia or related disorders, who have persistent auditory hallucinations despite trying multiple antipsychotic medications. They must have an IQ of at least 70 and be within the first five years since their first psychotic episode. People can't join if they have hearing deficits, standard MRI contraindications like metal in their body, severe head injuries, certain medical conditions affecting brain function, substance use disorders (except cannabis), are pregnant/postpartum, or take sedatives.Check my eligibility
What is being tested?
The study tests Auditory Control Enhancement (ACE) using transcranial direct current stimulation (tDCS) during cognitive training to reduce treatment-resistant auditory hallucinations. Participants will be randomly assigned to receive either ACE or a sham tDCS while undergoing interviews, cognitive tests, EEG scans to measure brain activity non-invasively and MRI scans before and after the training sessions.See study design
What are the potential side effects?
Potential side effects from tDCS may include mild tingling on the scalp where electrodes are placed, itching under electrode sites during stimulation, fatigue following treatment sessions, headache or nausea. The EEG involves minimal risk aside from potential discomfort from gel used with sensors. MRIs are generally safe but can cause discomfort due to loud noises or claustrophobia.

ACES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a schizophrenia spectrum or related psychotic disorder.
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I still hear voices despite trying more than two antipsychotic drugs for over a month.
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I am between 18 and 40 years old.

ACES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3 minus week 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 minus week 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Blinding
Blood-Oxygen Level Dependent (BOLD) response modulation with tDCS current
+7 more
Secondary outcome measures
Change in MCCB Attention Scale Score
Change in MCCB Processing Speed Scale Score
Other outcome measures
Change in Auditory Hallucination Severity

ACES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Auditory Control Enhancement (ACE)Experimental Treatment2 Interventions
tDCS + ACCT
Group II: Sham tDCS + ACCTPlacebo Group2 Interventions
Sham tDCS + ACCT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2100

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Who is running the clinical trial?

Brian A Coffman, PhDLead Sponsor
National Institute of Mental Health (NIMH)NIH
2,799 Previous Clinical Trials
2,661,140 Total Patients Enrolled
~7 spots leftby Oct 2024
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