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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 3 minus week 1

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

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Brian A Coffman, PhDLead Sponsor

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 85 and older qualified for this research?

"This clinical trial has set the enrollment age limit between 18 and 40 years old."

Answered by AI

Does the research team have open spots for volunteers?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this research initiative, which was initially posted on September 5th 2023, is actively seeking participants. Approximately 24 subjects are needed at a single site for the trial to be successful."

Answered by AI

Who is most likely to benefit from participating in this research?

"For consideration in this clinical trial, volunteers must suffer auditory hallucinations and be between the ages of 18 to 40. The total number of participants being sought is 24 individuals."

Answered by AI

How many test subjects are included in the scope of this clinical trial?

"Affirmative. The evidence on clinicaltrials.gov demonstrates that this study, first posted on September 5th 2023, is actively recruiting volunteers for the trial. 24 participants must be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auditory Control Enhancement (ACE) in Schizophrenia

Brian A Coffman, PhD 2023. "Auditory Control Enhancement (ACE) in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06155695.

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