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

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769507
• Other study ID #: UiB-BFS-01/2016
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Mental Disorders
• Psychotic Disorders

Intervention

Device:
• DC Stimulator PLUS (NeuroConn)

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory Hallucination Rating Scale (AHRS)	Measure for severity of hallucinations	Change from Baseline to immediately after treatment and 3 months after treatment
Primary	Questionnaire for Psychotic Experiences (QPE)	Measure for severity of hallucinations	Change from Baseline to immediately after treatment and 3 months after treatment
Primary	Positive and Negative Syndrome Scale (PANSS)	Measure for positive and negative symptoms in psychotic disorders	Change from Baseline to immediately after treatment and 3 months after treatment
Primary	Hallucinations App	iPhone/iPod application for self-ratings of auditory hallucinations	Continuously between baseline and 3 months after treatment
Primary	Hallucination Change Scale (HCS)	Measure for changes in severity of auditory hallucinations	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Stroop task	Measure of executive functioning	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Trailmaking test A and B	Measure of visuomotor speed	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Expectations Questionnaire	prior expectations participants have regarding the outcome of the treatment on a scale from 0 ("The treatment will have no effect") to 10 ("The treatment will make the voices go away entirely.")	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Adverse Effects Questionnaire	The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire	The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program
Secondary	The Clinical Global Impressions Scale - Severity	Measure of global functioning	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Global Assessment of Functioning	Measure of global functioning	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Shape, size, and integrity of gray and white matter structures in the brain	Structural Magnetic Resonance Imaging (MRI)	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions	MR spectroscopy	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	BOLD (Blood Oxygenation Level Dependent signal) response during resting state	Resting state functional MRI	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Dichotic listening paradigm	Measure of executive functioning	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	Dichotic listening paradigm	Measure of language lateralization	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	BOLD response during dichotic listening paradigm	Changes in brain activity in the left dorsolateral prefrontal cortex and the peri-Sylvian language regions	Change from Baseline to immediately after treatment and 3 months after treatment
Secondary	White matter structure and connectivity	MR Diffusion Tensor Imaging	Change from Baseline to immediately after treatment and 3 months after treatment