Schizophrenia
Conditions
Keywords
TDCS
Brief summary
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).
Detailed description
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.
Interventions
DEVICEIntervention 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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) primary diagnosis of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-Version IV) schizophrenia or schizoaffective disorder * Ages 8 to 25 years-old * Persistent auditory hallucinations * Full Scale intelligent quotient (IQ) greater than 60. * Stable antipsychotic medication for \> 4 weeks * If female and not infertile patient must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment or an interuterine device (IUD). * Legal guardian has provided written informed consent and the subject has provided written informed assent when able. Expectation that a majority of subjects will be able to assent but the potential for the younger children and/or those that are of borderline intellectual functioning will not be able to assent.
Exclusion criteria
* History of alcohol, substance dependence or abuse in the past 90 days * Open skin wounds that would preclude use of TDCS electrodes * If female, pregnancy or breast feeding, as determined during eligibility pre-screen call * Subjects exhibiting significant ongoing severe disruptive, aggressive, self-injurious, or sexually inappropriate behavior will not be eligible for enrollment. * Presence of any medical condition that would make treatment with tDCS less safe. This includes any implanted metal device or any cardiac pacemaker. Subjects with a history of a seizure disorder are permitted if the subject has been seizure free for 6 months and is currently treated with an anticonvulsant that has been stable for 4 weeks. * Presence of any other condition that would make the participants unable to comply with the requirements of the study for any reason. This may include an appreciable hearing or visual impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) | 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 | 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. |
| Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Intervention Active tDCS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: 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
Population: Entire time period was not achieved; participant was only followed for 2 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Active tDCS | Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale | Baseline | 31 score on a scale | Standard Deviation 0 |
| Intervention Active tDCS | Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale | Same day post TDCS | 20 score on a scale | Standard Deviation 0 |
| Intervention Active tDCS | Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale | 2 weeks post baseline | 17 score on a scale | Standard Deviation 0 |
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.
Time frame: 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
Population: Entire time period was not achieved; participant was only followed for 2 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Active tDCS | Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) | Baseline | 6 score on a scale | Standard Deviation 0 |
| Intervention Active tDCS | Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) | Same day post TDCS | 6 score on a scale | — |
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.
Time frame: 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
Population: Entire time period was not achieved; participant was only followed for 2 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Active tDCS | Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) | Baseline | 87 units on a scale | Standard Deviation 0 |
| Intervention Active tDCS | Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) | Same day post TDCS | 78 units on a scale | Standard Deviation 0 |