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Youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory hallucinations after one week of twice daily treatment with transcranial direct current stimulation (tDCS).
Background: Early onset schizophrenia (EOS) involves positives symptoms such as psychotic behaviors, as well as negative symptoms such as disruptions to normal emotions and behaviors. Antipsychotics are the primary method of treatment in pediatric populations, but can produce unpleasant or dangerous side effects. Medication response is highly variable. Recent evidence demonstrates transcranial Direct Current Stimulation (tDCS) relieving auditory hallucinations (AH) associated with schizophrenia in adults, and to a lesser degree negative and cognitive symptomology. Such studies provide important scientific and technical knowledge that may be applied to pediatric populations.
Hypothesis: 1. Primary: Youths with EOS will demonstrate amelioration of AH after administration of tDCS. 2. TDCS will be well-tolerated in pediatric populations with minimal adverse side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Active tDCS | Experimental | Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Active tDCS | Device | Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale | The primary efficacy assessment is the mean change from baseline to the last observed post-baseline visit in total score on the Auditory Hallucination Rating Scale (AHRS). Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms. | Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified every 3 months for up to 12 months, 2 week time point achieved |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) | The primary secondary outcome measure will be the change in severity of other symptoms of schizophrenia, assessed using the Positive and Negative Syndrome Scale (PANSS) from baseline to last observation, expected average of every 3 months. The PANSS can be computed as a dimensional scale including positive, negative, depression, disorganization, and grandiosity/excitement. Both the positive and negative scales have minimum scores of 7 and maximum scores of 49. The general scale has a minimum score of 16 and a maximum score of 112. Total score minimum is 30 and total score maximum is 210. Higher scores indicate more severe symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernest Pedapati | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22581236 | Background | Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Active tDCS | Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Active tDCS | Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale | The primary efficacy assessment is the mean change from baseline to the last observed post-baseline visit in total score on the Auditory Hallucination Rating Scale (AHRS). Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms. | Entire time period was not achieved; participant was only followed for 2 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified every 3 months for up to 12 months, 2 week time point achieved |
|
6 weeks
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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 | Intervention Active tDCS | Affected subjects receiving up to 2 milliamps (mA) active tDCS, open label Intervention Active tDCS: Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ernest Pedapati | Cincinnati Childrens Hospital Medical Center | 5137361901 | ernest.pedapati@cchmc.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Baseline to last observation: at baseline, following 5 days of TDCS, and pre-specified 1, 3, and 6 months, expected average of 3 months for us to 12 months, post-TDCS timepoint achieved |
| Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) | Mean change from baseline to the last observed post-baseline visit Clinical Global Impression (CGI-S) severity scales. The minimum score on the CGI-S is 1 and the maximum score is 7. A higher score indicates more severe illness. | Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified at 1, 3, and 6 months, expected average of 3 months for up to 12 months, post-TDCS time point achieved |
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| Secondary | Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) | The primary secondary outcome measure will be the change in severity of other symptoms of schizophrenia, assessed using the Positive and Negative Syndrome Scale (PANSS) from baseline to last observation, expected average of every 3 months. The PANSS can be computed as a dimensional scale including positive, negative, depression, disorganization, and grandiosity/excitement. Both the positive and negative scales have minimum scores of 7 and maximum scores of 49. The general scale has a minimum score of 16 and a maximum score of 112. Total score minimum is 30 and total score maximum is 210. Higher scores indicate more severe symptoms. | Entire time period was not achieved; participant was only followed for 2 weeks. | Posted | Mean | Standard Deviation | units on a scale | Baseline to last observation: at baseline, following 5 days of TDCS, and pre-specified 1, 3, and 6 months, expected average of 3 months for us to 12 months, post-TDCS timepoint achieved |
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| Secondary | Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) | Mean change from baseline to the last observed post-baseline visit Clinical Global Impression (CGI-S) severity scales. The minimum score on the CGI-S is 1 and the maximum score is 7. A higher score indicates more severe illness. | Entire time period was not achieved; participant was only followed for 2 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline to last observation: at baseline, following 5 days of TDCS, pre-specified at 1, 3, and 6 months, expected average of 3 months for up to 12 months, post-TDCS time point achieved |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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