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Completed

NCT Number: NCT02769507

Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations

The present study aims to investigate whether transcranial direct current stimulation (tDCS) reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes of tDCS will be examined.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5009, Norway

About this study

The majority of patients with psychosis experience hallucinations, particularly auditory hallucinations are frequent. The hallucinations often leads to massive distress and impairments in social functioning and sometimes even order patients to commit acts of violence against themselves or others. The standard treatment for auditory hallucinations is antipsychotic medication. However, side-effects can be severe and about 25-30% of the patients do not respond to the medication. Transcranial direct current stimulation is a non-invasive brain stimulation technique, which modulates cortical excitability in a pain-free free with mild transient adverse effects, if any. Typically, cortical excitability underneath the anode is boosted while cathodal stimulation has inhibitory effects. Previous studies found that 2 daily sessions of 20 min tDCS for five subsequent days may reduce auditory hallucinations. Investigators want to further assess the efficacy of tDCS in sample that is large enough to detect medium to large effects. In addition, investigators want to investigate the neural mechanisms that underlie the tDCS treatment by examining various neuroimaging parameters before, immediately after treatment, and 3 months after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with schizophrenia spectrum disorder or other psychotic disorder
  • Frequent auditory hallucinations (at least 5 times a week).
  • Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks.
  • Mentally competent for informed consent.
  • Provided informed consent.

Exclusion criteria

  • Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
  • History of seizures, or a history of seizures in first-degree relatives.
  • History of eye trauma with a metal object or professional metal workers
  • History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
  • Skin disease on the scalp on the position of the tDCS electrodes
  • Coercive treatment based on a judicial ruling
  • Pregnancy in female patients

Treatment and study plan

DC Stimulator PLUS (NeuroConn)

Device

Primary outcomes

  1. Auditory Hallucination Rating Scale (AHRS)

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations

  2. Hallucination Change Scale (HCS)

    Time frame: Change from Baseline to immediately after treatment

    Measure for changes in severity of auditory hallucinations; participants rated in percent how much their symptoms had improved (or worsened). The range is thus -100 (symptoms reduced by 100%) to +100 (symptoms worsened by 100%)

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Positive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms

  2. Stroop Task

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance

  3. Trailmaking Test B

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of visuomotor speed

  4. Apathy Evaluation Scale

    Time frame: Before, immediately after treatment, and at 3 month follow-up

    Total sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy

  5. The Clinical Global Impressions Scale - Severity

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of global functioning; rated by clinician on a 7-point scale, with the severity of illness scale rated from 1 (normal) through to 7 (most severely ill)

  6. Global Assessment of Functioning - S

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of global functioning - Symptoms, rated by clinician; measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100, where 0 is severely impacted in daily life by symptoms and 100 is not affected at all

  7. Dichotic Listening Paradigm

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of executive functioning, forced left condition, percentage reported from left ear

  8. Dichotic Listening Laterality Index

    Time frame: Change from Baseline to immediately after treatment and 3 months after treatment

    Measure of language lateralization, laterality index in non-forced condition, laterality index is computed according to formula: LI=[(R-L)/(R+L)]*100, where "L" and "R" are the number of correct left and right ear responses, respectively. values can range between -100 (only syllables from left ear correctly reported and +100 (only correct syllables from right ear reported)

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Helse-Bergen HF

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 11, 2016
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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