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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 : September 25, 2019
Sponsor:
Collaborator:
Helse-Bergen HF
Information provided by (Responsible Party):
Marco Hirnstein, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Device: DC Stimulator PLUS (NeuroConn) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Study Start Date : July 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Device: DC Stimulator PLUS (NeuroConn)



Primary Outcome Measures :
  1. Auditory Hallucination Rating Scale (AHRS) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for severity of hallucinations

  2. Questionnaire for Psychotic Experiences (QPE) [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure for severity of hallucinations

  3. 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

  4. Hallucinations App [ Time Frame: Continuously between baseline and 3 months after treatment ]
    iPhone/iPod application for self-ratings of auditory hallucinations

  5. 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


Secondary Outcome Measures :
  1. Stroop task [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of executive functioning

  2. Trailmaking test A and B [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of visuomotor speed

  3. 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.")

  4. 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

  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

  6. Global Assessment of Functioning [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of global functioning

  7. 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)

  8. 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

  9. 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

  10. Dichotic listening paradigm [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of executive functioning

  11. Dichotic listening paradigm [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    Measure of language lateralization

  12. 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

  13. White matter structure and connectivity [ Time Frame: Change from Baseline to immediately after treatment and 3 months after treatment ]
    MR Diffusion Tensor Imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769507


Contacts
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Contact: Marco Hirnstein, PhD +47 555 86082 marco.hirnstein@uib.no

Locations
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Norway
University of Bergen Recruiting
Bergen, Hordaland, Norway, 5009
Contact: Marco Hirnstein, PhD    +4747515850    marco.hirnstein@uib.no   
Contact: Anne Samdal Thomassen    +4747515850    synnove.samdal.thomassen@helse-bergen.no   
Sponsors and Collaborators
University of Bergen
Helse-Bergen HF
Investigators
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Principal Investigator: Marco Hirnstein, PhD University of Bergen

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Responsible Party: Marco Hirnstein, PhD, University of Bergen
ClinicalTrials.gov Identifier: NCT02769507     History of Changes
Other Study ID Numbers: UiB-BFS-01/2016
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".
Additional relevant MeSH terms:
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Hallucinations
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms