EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

NCT ID: NCT03852706

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-03-25

Brief 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.

Detailed 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

LORETA

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.

Group Type: EXPERIMENTAL

LORETA

Intervention Type: OTHER

Twenty sessions of neurofeedback training using LORETA in combination with z-scores.

Treatment as usual

Intervention Type: OTHER

Treatment-as-usual

Treatment as usual

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

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

Treatment-as-usual

Interventions

LORETA

Twenty sessions of neurofeedback training using LORETA in combination with z-scores.

Intervention Type: OTHER

Treatment as usual

Treatment-as-usual

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actualise

OTHER

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Simon McCarthy-Jones

Associate Professor in Clinical Psychology and Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon McCarthy-Jones

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Tallaght University Hospital / St. James' Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

25911

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

206789

Identifier Type: -

Identifier Source: org_study_id