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

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
DC Stimulator PLUS (NeuroConn)
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS

sham tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Auditory Hallucination Rating Scale (AHRS)
Measure for severity of hallucinations
Questionnaire for Psychotic Experiences (QPE)
Measure for severity of hallucinations
Positive and Negative Syndrome Scale (PANSS)
Measure for positive and negative symptoms in psychotic disorders
Hallucinations App
iPhone/iPod application for self-ratings of auditory hallucinations
Hallucination Change Scale (HCS)
Measure for changes in severity of auditory hallucinations

Secondary Outcome Measures

Stroop task
Measure of executive functioning
Trailmaking test A and B
Measure of visuomotor speed
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.")
Adverse Effects Questionnaire
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
The Clinical Global Impressions Scale - Severity
Measure of global functioning
Global Assessment of Functioning
Measure of global functioning
Shape, size, and integrity of gray and white matter structures in the brain
Structural Magnetic Resonance Imaging (MRI)
GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions
MR spectroscopy
BOLD (Blood Oxygenation Level Dependent signal) response during resting state
Resting state functional MRI
Dichotic listening paradigm
Measure of executive functioning
Dichotic listening paradigm
Measure of language lateralization
BOLD response during dichotic listening paradigm
Changes in brain activity in the left dorsolateral prefrontal cortex and the peri-Sylvian language regions
White matter structure and connectivity
MR Diffusion Tensor Imaging

Full Information

First Posted
May 6, 2016
Last Updated
August 6, 2020
Sponsor
University of Bergen
Collaborators
Helse-Bergen HF
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1. Study Identification

Unique Protocol Identification Number
NCT02769507
Brief Title
Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Official Title
Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Helse-Bergen HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
DC Stimulator PLUS (NeuroConn)
Primary Outcome Measure Information:
Title
Auditory Hallucination Rating Scale (AHRS)
Description
Measure for severity of hallucinations
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Questionnaire for Psychotic Experiences (QPE)
Description
Measure for severity of hallucinations
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Measure for positive and negative symptoms in psychotic disorders
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Hallucinations App
Description
iPhone/iPod application for self-ratings of auditory hallucinations
Time Frame
Continuously between baseline and 3 months after treatment
Title
Hallucination Change Scale (HCS)
Description
Measure for changes in severity of auditory hallucinations
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Secondary Outcome Measure Information:
Title
Stroop task
Description
Measure of executive functioning
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Trailmaking test A and B
Description
Measure of visuomotor speed
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Expectations Questionnaire
Description
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.")
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Adverse Effects Questionnaire
Description
The presence and severity of side-effects will be monitored using the tDCS 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
Title
The Clinical Global Impressions Scale - Severity
Description
Measure of global functioning
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Global Assessment of Functioning
Description
Measure of global functioning
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Shape, size, and integrity of gray and white matter structures in the brain
Description
Structural Magnetic Resonance Imaging (MRI)
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
GABA and glutamate levels in the dorsolateral prefrontal cortex and peri-Sylvian regions
Description
MR spectroscopy
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
BOLD (Blood Oxygenation Level Dependent signal) response during resting state
Description
Resting state functional MRI
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Dichotic listening paradigm
Description
Measure of executive functioning
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
Dichotic listening paradigm
Description
Measure of language lateralization
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
BOLD response during dichotic listening paradigm
Description
Changes in brain activity in the left dorsolateral prefrontal cortex and the peri-Sylvian language regions
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment
Title
White matter structure and connectivity
Description
MR Diffusion Tensor Imaging
Time Frame
Change from Baseline to immediately after treatment and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Hirnstein, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5009
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".

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

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