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

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ClinicalTrials.gov Identifier: NCT02764164
Recruitment Status : Terminated (Lack of funding)
First Posted : May 6, 2016
Results First Posted : October 20, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Device: Intervention Active tDCS
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1
Completed 1 [1]
Not Completed 0
[1]
Duration flexible up to 12mo, ended early (funding), 2 week time point achieved
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description

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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Change in Severity of Auditory Hallucinations Measured by Auditory Hallucinations Rating Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entire time period was not achieved; participant was only followed for 2 weeks.
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 1 participants
31  (0)
Same day post TDCS Number Analyzed 1 participants
20  (0)
2 weeks post baseline Number Analyzed 1 participants
17  (0)
3 months post baseline Number Analyzed 0 participants
6 months post baseline Number Analyzed 0 participants
9 months post baseline Number Analyzed 0 participants
12 months post baseline Number Analyzed 0 participants
2.Secondary Outcome
Title Change in Schizophrenia Symptom Type as Measured by the Positive and Negative Syndrome Scale (PANSS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entire time period was not achieved; participant was only followed for 2 weeks.
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 1 participants
87  (0)
Same day post TDCS Number Analyzed 1 participants
78  (0)
1 month post baseline Number Analyzed 0 participants
3 months post baseline Number Analyzed 0 participants
6 months post baseline Number Analyzed 0 participants
9 months post baseline Number Analyzed 0 participants
12 months post baseline Number Analyzed 0 participants
3.Secondary Outcome
Title Change in Disorder Severity as Measured by Clinical Global Impressions Severity Scales (CGI-S)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entire time period was not achieved; participant was only followed for 2 weeks.
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 1 participants
6  (0)
Same day post TDCS Number Analyzed 1 participants
6
1 month post baseline Number Analyzed 0 participants
3 months post baseline Number Analyzed 0 participants
6 months post baseline Number Analyzed 0 participants
9 months post baseline Number Analyzed 0 participants
12 months post baseline Number Analyzed 0 participants
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Active tDCS
Hide Arm/Group Description

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.

All-Cause Mortality
Intervention Active tDCS
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
Intervention Active tDCS
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Active tDCS
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ernest Pedapati
Organization: Cincinnati Childrens Hospital Medical Center
Phone: 5137361901
EMail: ernest.pedapati@cchmc.org
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02764164    
Other Study ID Numbers: 2014-6134
First Submitted: August 3, 2015
First Posted: May 6, 2016
Results First Submitted: August 28, 2020
Results First Posted: October 20, 2020
Last Update Posted: March 5, 2021