Trial Outcomes & Findings for Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS) (NCT NCT02764164)

Last Updated: 2021-03-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2021-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Current Stimulation (TDCS) for Auditory Hallucinations in Early Onset Schizophrenia (EOS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Active tDCS n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Active tDCS n=1 Participants 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.
Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale Baseline	31 score on a scale Standard Deviation 0
Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale Same day post TDCS	20 score on a scale Standard Deviation 0
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Active tDCS n=1 Participants 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.
Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS) Baseline	87 units on a scale Standard Deviation 0
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Active tDCS n=1 Participants 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.
Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) Baseline	6 score on a scale Standard Deviation 0
Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S) Same day post TDCS	6 score on a scale

Adverse Events

Intervention Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ernest Pedapati

Cincinnati Childrens Hospital Medical Center

Phone: 5137361901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place