Remediation of Auditory Recognition in Schizophrenia With tDCS

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02869334
• Collaborator: Nathan Kline Institute for Psychiatric Research (Other)
• Enrollment: 20
• Location: 1
• Arms: 3
• Actual Duration (Months): 44
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS), when combined with different forms of computer based training, improves the ability to discriminate small differences between sounds in people diagnosed with schizophrenia or schizoaffective disorder.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Device: Active Transcranial direct current stimulation (tDCS); Device: Sham Transcranial direct current stimulation (tDCS); Behavioral: Auditory Remediation; Behavioral: Control computer activities	N/A

Detailed Description

This study uses an experimental procedure called transcranial direct current stimulation (tDCS). Little is known about how tDCS affects the brain or why some people diagnosed with schizophrenia or schizoaffective disorder have trouble with certain kinds of hearing. This study is being done to see if an experimental computer training program, when combined with tDCS, can help people to hear better. In tDCS, a small amount of electricity is passed through electrodes placed on the head that is able to stimulate the brain. By stimulating the brain, the investigators believe that the functioning of the brain can be altered. This study will test whether such stimulation of the brain, when done with computer training, can improve hearing ability and if this improvement helps in other ways, like detecting changes in someone's tone of voice or understanding other people's emotions better. The data being collected aims to better understand how the brain processes sounds and how tDCS affects the brain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Remediation of Auditory Recognition in Schizophrenia With Transcranial Direct Current Stimulation (tDCS)
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Auditory remediation with active tDCS Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Device: Active Transcranial direct current stimulation (tDCS); Active tDCS, where an extremely weak electric current passes through the brain; Behavioral: Auditory Remediation; Computer program designed to improve discrimination between sounds
Experimental: Auditory remediation with sham tDCS Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Device: Sham Transcranial direct current stimulation (tDCS); Sham (inactive or placebo) tDCS; Behavioral: Auditory Remediation; Computer program designed to improve discrimination between sounds
Sham Comparator: Control (computer games with sham tDCS) Non-remediation, control computer activities (e.g. games) with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week	Device: Sham Transcranial direct current stimulation (tDCS); Sham (inactive or placebo) tDCS; Behavioral: Control computer activities; Computer program (e.g. games), which are not designed to improve discrimination between sounds

Outcome Measures

Primary Outcome Measures

1. Auditory Tone Matching Task [Change in performance from Baseline at completion of training (week 16)]

   Ability to match tones following brief delay

Secondary Outcome Measures

1. Auditory Emotion Recognition (AER) Task [Change in performance from Baseline at completion of training (week 16)]

   Ability to detect emotion based on tone of voice

2. ER-40 [Change in performance from Baseline at completion of training (week 16)]

   Penn Emotion Recognition Test-40 Faces Version

3. The Awareness of Social Inference Test (TASIT) [Change in performance from Baseline at completion of training (week 16)]

   The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.

4. Auditory Mismatch Negativity (MMN) [Change in performance from Baseline at completion of training (week 16)]

   Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-55

• Primary diagnosis of Schizophrenia or schizoaffective disorder

• English fluency

• Willing/capable to provide informed consent

• Auditory tone matching deficits

• Receiving stable doses of antipsychotic medication(s) for at least 2 weeks

• IQ>75

Exclusion Criteria:

• Serious neurological disorder or medical condition/ treatment known to affect the brain. Neurological Disorder that affects the central nervous system (CNS), such as epilepsy, neurodegenerative disorders, movement disorders and sensory disorders.

• Current or past history (within the last 6 months) of substance abuse or dependence (excluding nicotine)

• Pregnancy or breastfeeding

• Taking anticholinergic medication (e.g. Cogentin, Thorazine, Clozaril, thioridazine)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Nathan Kline Institute for Psychiatric Research

Investigators

• Principal Investigator: Daniel Javitt, MD, PhD, NY State Psychiatric Institute, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 27, 2016

More Information

Additional Information:

• New York State Psychiatric Institute
• Department of Psychiatry, Columbia University Medical Center

Publications

None provided.

• Responsible Party: Daniel C. Javitt, Professor, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02869334
• Other Study ID Numbers: 7266
• First Posted: Aug 16, 2016
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Period Title: Overall Study
STARTED	10	10
COMPLETED	2	3
NOT COMPLETED	8	7

Baseline Characteristics

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS	Total
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	3 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.0 (9.9)	44.7 (14.4)	42.4 (11.8)
Sex: Female, Male (Count of Participants)
Female	1 50%	1 33.3%	2 40%
Male	1 50%	2 66.7%	3 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%	1 33.3%	2 40%
Not Hispanic or Latino	1 50%	2 66.7%	3 60%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 100%	2 66.7%	4 80%
White	0 0%	1 33.3%	1 20%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%
Tone matching (i.e. ability to match tones following brief delay) (percent correct) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent correct]	53.6 (5.1)	54.3 (12.7)	54.0 (9.3)

Outcome Measures

1. Primary Outcome

Title	Auditory Tone Matching Task
Description	Ability to match tones following brief delay
Time Frame	Change in performance from Baseline at completion of training (week 16)

Outcome Measure Data

Analysis Population Description

completers

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Measure Participants	2	3
Mean (Standard Deviation) [%correct, different trials]	-4.3 (12.1)	4.8 (9.3)

2. Secondary Outcome

Title	Auditory Emotion Recognition (AER) Task
Description	Ability to detect emotion based on tone of voice
Time Frame	Change in performance from Baseline at completion of training (week 16)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Measure Participants	2	3
Mean (Standard Deviation) [%correct]	-3.0 (8.6)	5.1 (12.2)

3. Secondary Outcome

Title	ER-40
Description	Penn Emotion Recognition Test-40 Faces Version
Time Frame	Change in performance from Baseline at completion of training (week 16)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Measure Participants	2	2
Mean (Standard Deviation) [percent correct]	-5.0 (3.5)	-1.3 (1.8)

4. Secondary Outcome

Title	The Awareness of Social Inference Test (TASIT)
Description	The TASIT is a measure of social cognition, theory of mind as reflected in the ability to detect lies/sarcasm while viewing social vignettes. Total scores range from 0-100% correct. Higher numbers (positive change) are considered better.
Time Frame	Change in performance from Baseline at completion of training (week 16)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Measure Participants	2	3
Mean (Standard Deviation) [score on a scale]	10 (4.2)	0 (6.8)

5. Secondary Outcome

Title	Auditory Mismatch Negativity (MMN)
Description	Change in event related potentials (ERP) acquired during a task of auditory mismatch negativity (MMN), assessed with electroencephalography (EEG)
Time Frame	Change in performance from Baseline at completion of training (week 16)

Outcome Measure Data

Analysis Population Description

Subjects who completed post-testing and had usable data

Arm/Group Title	Auditory Remediation With Active tDCS	Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds	Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
Measure Participants	1	2
Mean (Standard Deviation) [microvolt]	-1.47 (0)	-.98 (1.07)

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Auditory Remediation With Active tDCS		Auditory Remediation With Sham tDCS
Arm/Group Description	Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds		Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds
All Cause Mortality
	Auditory Remediation With Active tDCS		Auditory Remediation With Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Serious Adverse Events
	Auditory Remediation With Active tDCS		Auditory Remediation With Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Auditory Remediation With Active tDCS		Auditory Remediation With Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/3 (0%)
Nervous system disorders
sedation	1/2 (50%)	1	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.