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

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ClinicalTrials.gov Identifier: NCT02769507
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Helse-Bergen HF
Information provided by (Responsible Party):
Marco Hirnstein, University of Bergen

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 11, 2016
Last Update Posted Date October 15, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Auditory Hallucination Rating Scale (AHRS) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for severity of hallucinations
  • Questionnaire for Psychotic Experiences (QPE) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for severity of hallucinations
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for positive and negative symptoms in psychotic disorders
  • Hallucinations App [ Time Frame: Continuously between baseline and 3 months after treatment ]
    iPhone/iPod application for self-ratings of auditory hallucinations
  • Hallucination Change Scale (HCS) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for changes in severity of auditory hallucinations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02769507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • Stroop task [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of executive functioning
  • Trailmaking test A and B [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of visuomotor speed
  • Expectations Questionnaire [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    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.")
  • Adverse Effects Questionnaire [ Time Frame: The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program ]
    The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
  • The Clinical Global Impressions Scale - Severity [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of global functioning
  • Global Assessment of Functioning [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of global functioning
  • Shape, size, and integrity of gray and white matter structures in the brain [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Structural Magnetic Resonance Imaging (MRI)
  • GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    MR spectroscopy
  • BOLD (Blood Oxygenation Level Dependent signal) response during resting state [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Resting state functional MRI
  • Dichotic listening paradigm [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of executive functioning
  • Dichotic listening paradigm [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of language lateralization
  • BOLD response during dichotic listening paradigm [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Changes in brain activity in the left dorsolateral prefrontal cortex and the peri-Sylvian language regions
  • White matter structure and connectivity [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    MR Diffusion Tensor Imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Official Title  ICMJE Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psychotic Disorders
Intervention  ICMJE Device: DC Stimulator PLUS (NeuroConn)
Study Arms  ICMJE
  • Experimental: real tDCS
    DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri‐Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.
    Intervention: Device: DC Stimulator PLUS (NeuroConn)
  • Sham Comparator: sham tDCS
    DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.
    Intervention: Device: DC Stimulator PLUS (NeuroConn)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marco Hirnstein, PhD +47 555 86082 marco.hirnstein@uib.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769507
Other Study ID Numbers  ICMJE UiB-BFS-01/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".
Responsible Party Marco Hirnstein, University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE Helse-Bergen HF
Investigators  ICMJE
Principal Investigator: Marco Hirnstein, PhD University of Bergen
PRS Account University of Bergen
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP