TerminatedNot Applicable

EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

Stopped: A national Covid-19 lockdown prevented completion of the trial

Ireland4 participantsStarted 2019-03-01

Plain-language summary

This study's primary objective is to perform a randomized controlled pilot study to assess the feasibility of using EEG-based neurofeedback to reduce the severity of treatment-resistant auditory verbal hallucinations ('hearing voices') in patients diagnosed with schizophrenia. Patients will be randomized to receive either EEG-based neurofeedback or treatment-as-usual.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Are ≥ 18 years old * Have a clinical diagnosis of a schizophrenia-spectrum disorder * Have been experiencing auditory verbal hallucinations for at least one year * Score 2 or more on the frequency item of the auditory hallucinations subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH; Haddock et al., 1999) at time of initial assessment (representing voices occurring at least once a day) * Are deemed refractory to antipsychotic treatment (defined as still hearing voices despite 4-6 weeks of treatment with two different antipsychotics) * Have been on a stable dose of antipsychotic medication for the three months prior to study enrolment * Are right-handed, as determined by the Edinburgh Handedness Inventory (Oldfield, 1971) * Are able to provide written, informed consent. Exclusion Criteria: * Having a diagnosed substance abuse disorder * Prior head injury with loss of consciousness for more than five minutes * At immediate risk of harm to self or others.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: 24 months

Willingness of participants to be randomised.

Timeframe: 24 months

Willingness of participants to complete assessments

Timeframe: 24 months

Drop-out rate: LORETA condition

Timeframe: 24 months

Success of blinding of raters

Timeframe: 24 months

Rates of adverse psychiatric events

Timeframe: 24 months

Drop-out rate: Controls

Timeframe: 24 months

Trial details

NCT IDNCT03852706

SponsorUniversity of Dublin, Trinity College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-25

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment rate

Timeframe: 24 months

Willingness of participants to be randomised.

Timeframe: 24 months

Willingness of participants to complete assessments

Timeframe: 24 months

Drop-out rate: LORETA condition

Timeframe: 24 months

Success of blinding of raters

Timeframe: 24 months

Rates of adverse psychiatric events

Timeframe: 24 months

Drop-out rate: Controls

Timeframe: 24 months