Clinical Trials Logo
  1. Home
  2. Schizophrenia
  3. NCT03852706

EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED) — HALFEED  

Schizophrenia Clinical Trial

Official title:
A Randomized Controlled Pilot Trial of Low-resolution Brain Electromagnetic Tomography (LORETA) Neurofeedback Training for Treatment-resistant Auditory Verbal Hallucinations in Schizophrenia

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03852706
Study type Interventional
Source University of Dublin, Trinity College
Contact
Status Terminated
Phase N/A
Start date March 1, 2019
Completion date March 25, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A