EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

University of Dublin, Trinity College

Status: Terminated

Conditions: Schizophrenia

Treatments: Other: LORETA; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03852706

25911 (Other Grant/Funding Number)

206789

Details and patient eligibility

About

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.

Full description

Auditory verbal hallucinations (AVH) are experienced by up to 80% of patients diagnosed with schizophrenia, where they can cause significant occupational and social impairment. Current treatments are incompletely effective. Around 25-30% of AVH are refractory to antipsychotic drugs, and cognitive behavioural therapy only shows a small-medium effect size. Initially promising studies of neurostimulation have shown smaller effect sizes as better controlled trials have been conducted. There is hence the need for innovative new treatments. One potential option is neurofeedback training. The primary objective of study is to perform a randomized, controlled, rater-blinded pilot trial (n=40) of EEG neurofeedback for AVH in patients with treatment-resistant schizophrenia, to assess trial process, which will then inform a future definitive trial. The secondary objective is to calculate a 95% confidence interval that will allow interpretation of statistical difference between neurofeedback and treatment-as-usual groups to assess neurofeedback for reducing auditory verbal hallucinations. Participants will be randomly allocated to either a neurofeedback (plus treatment-as-usual) or treatment-as-usual alone condition. Neurofeedback will employ Z-score based LORETA (Low Resolution Brain Electromagnetic Tomography). After a baseline assessment, twenty sessions of personalized neurofeedback training will be delivered over a period of approximately four months. This is the first registered trial of EEG neurofeedback for hallucinations. The primary focus of the pilot trial is on feasibility. However, a 95% confidence interval will be determined for the difference on PSYRATS-AH and AHRS scores between neurofeedback and treatment-as-usual to help inform a future definitive trial.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

LORETA

Experimental group

Description:

In the first session, Low Resolution Brain Electromagnetic Tomography (LORETA) will be used in combination with Z-scores to identify participants' resting state EEG differences relative to a database of norms of their demographic. EEG abnormalities which are consistent with the research literature on neural changes associated with AVH will then be targeted for normalization using neurofeedback training using LORETA in combination with Z-scores.

Treatment:

Other: LORETA

Other: Treatment as usual

Treatment as usual

Other group

Description:

Maintenance use of an atypical antipsychotic (e.g., clozapine) with support, when needed, of a community nurse.

Treatment:

Other: Treatment as usual