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| Name | Class |
|---|---|
| Helse-Bergen HF | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real tDCS | Experimental | 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. |
|
| sham tDCS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC Stimulator PLUS (NeuroConn) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Auditory Hallucination Rating Scale (AHRS) | Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations | Change from Baseline to immediately after treatment and 3 months after treatment |
| Hallucination Change Scale (HCS) | 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%) | Change from Baseline to immediately after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Positive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms | Change from Baseline to immediately after treatment and 3 months after treatment |
| Stroop Task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Hirnstein, PhD | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bergen | Bergen | Hordaland | 5009 | Norway |
Data will be shared with the ERC Advanced Projects Advanced Grant #249516 "VOICE" and #693124 "ONOFF".
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. DC Stimulator PLUS (NeuroConn) |
| FG001 | 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. DC Stimulator PLUS (NeuroConn) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. DC Stimulator PLUS (NeuroConn) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Auditory Hallucination Rating Scale (AHRS) | Self-report measure for severity of hallucinations; consists of seven items; Sum can range from 2 to 41; higher values indicate more severe hallucinations | Posted | Mean | Standard Deviation | AHRS total score | Change from Baseline to immediately after treatment and 3 months after treatment |
|
3 months after treatment
Data on adverse events was collected with a questionnaire based on Brunoni, A. R., Amadera, J., Berbel, B., Volz, M. S., Rizzerio, B. G., & Fregni, F. (2011). A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. International Journal of Neuropsychopharmacology, 14(8), 1133-1145. https://doi.org/10.1017/s1461145710001690 that was completed after every tDCS session
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. DC Stimulator PLUS (NeuroConn) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant stopped treatment | Psychiatric disorders | Systematic Assessment | One participant who received real tDCS dropped out after two days of tDCS because the participant felt that the stimulation was aggravating her psychiatric symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Hirnstein | University of Bergen | +47 555 86082 | marco.hirnstein@uib.no |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2014 | May 18, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2024 | May 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Measure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance |
| Change from Baseline to immediately after treatment and 3 months after treatment |
| Trailmaking Test B | Measure of visuomotor speed | Change from Baseline to immediately after treatment and 3 months after treatment |
| Apathy Evaluation Scale | Total sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy | Before, immediately after treatment, and at 3 month follow-up |
| The Clinical Global Impressions Scale - Severity | 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) | Change from Baseline to immediately after treatment and 3 months after treatment |
| Global Assessment of Functioning - S | 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 | Change from Baseline to immediately after treatment and 3 months after treatment |
| Dichotic Listening Paradigm | Measure of executive functioning, forced left condition, percentage reported from left ear | Change from Baseline to immediately after treatment and 3 months after treatment |
| Dichotic Listening Laterality Index | 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) | Change from Baseline to immediately after treatment and 3 months after treatment |
| BG001 | 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. DC Stimulator PLUS (NeuroConn) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. DC Stimulator PLUS (NeuroConn) |
|
|
| Primary | Hallucination Change Scale (HCS) | 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%) | Posted | Mean | Standard Deviation | percentage | Change from Baseline to immediately after treatment |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) | Positive Sum Score; conducted by clinical rater; consists of 10 items, range 7-49; higher scores indicate more severe symptoms | Posted | Mean | Standard Deviation | Positive sum score | Change from Baseline to immediately after treatment and 3 months after treatment |
|
|
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| Secondary | Stroop Task | Measure of executive functioning, Stroop condition #3 in seconds; higher values indicate longer task duration and worse performance | Posted | Mean | Standard Deviation | seconds | Change from Baseline to immediately after treatment and 3 months after treatment |
|
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| Secondary | Trailmaking Test B | Measure of visuomotor speed | Posted | Mean | Standard Deviation | seconds | Change from Baseline to immediately after treatment and 3 months after treatment |
|
|
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| Secondary | Apathy Evaluation Scale | Total sum of AES score; consists of 18 items; range 18-72, higher values indicate higher degree of apathy | Posted | Mean | Standard Deviation | score on a scale | Before, immediately after treatment, and at 3 month follow-up |
|
|
|
| Secondary | The Clinical Global Impressions Scale - Severity | 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) | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to immediately after treatment and 3 months after treatment |
|
|
|
| Secondary | Global Assessment of Functioning - S | 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 | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to immediately after treatment and 3 months after treatment |
|
|
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| Secondary | Dichotic Listening Paradigm | Measure of executive functioning, forced left condition, percentage reported from left ear | Posted | Mean | Standard Deviation | percentage correct left ear reports | Change from Baseline to immediately after treatment and 3 months after treatment |
|
|
|
| Secondary | Dichotic Listening Laterality Index | 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) | Posted | Mean | Standard Deviation | laterality index, non-forced condition | Change from Baseline to immediately after treatment and 3 months after treatment |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | 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. DC Stimulator PLUS (NeuroConn) | 0 | 11 | 0 | 11 | 11 | 11 |
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| Headache | General disorders | Systematic Assessment |
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| neck pain | General disorders | Systematic Assessment |
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| scalp pain | General disorders | Systematic Assessment |
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| tingling | General disorders | Systematic Assessment |
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| itching | General disorders | Systematic Assessment |
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| burning sensation | General disorders | Systematic Assessment |
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| skin redness | General disorders | Systematic Assessment |
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| sleepiness | General disorders | Systematic Assessment |
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| trouble concentrating | General disorders | Systematic Assessment |
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| acute mood change | General disorders | Systematic Assessment |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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| 3 month follow-up |
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