Stimulating the Brain to Improve Self-Awareness

• Sponsor: The University of Texas at Dallas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03370341
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This study investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Device: active anodal tDCS; Device: sham tDCS	N/A

Detailed Description

Self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests.

Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears to be a promising therapeutic technique that may be useful for improving IA. This study will compare IA performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Stimulating the Brain to Improve Self-Awareness
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active anodal tDCS first, then Sham tDCS Active anodal tDCS (20 minutes) followed by behavioral testing; Washout (1 week); sham stimulation (20 minutes) followed by behavioral testing Intervention: Device: active anodal tDCS and sham tDCS	Device: active anodal tDCS; active anodal tDCS with behavioral tasks to assess IA; Device: sham tDCS; sham tDCS with behavioral tasks to assess IA
Sham Comparator: Sham tDCS first, then Active anodal tDCS Sham tDCS (20 minutes) followed by behavioral testing; Washout (1 week); Active anodal tDCS (20 minutes) followed by behavioral testing Intervention: Device: sham tDCS and sham tDCS	Device: active anodal tDCS; active anodal tDCS with behavioral tasks to assess IA; Device: sham tDCS; sham tDCS with behavioral tasks to assess IA

Outcome Measures

Primary Outcome Measures

1. Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation [Assessment will be completed 30 minutes after completion of the active/sham stimulation]

   Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.

Secondary Outcome Measures

1. Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation [Assessment will be completed 30 minutes after completion of the active/sham stimulation]

   Social Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.

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

• DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e., no hospitalizations) for at least 8 weeks and on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks

Exclusion Criteria:

• Presence or history of pervasive developmental disorder (e.g., autism) or mental retardation (defined as IQ <70) by DSM-IV criteria

• Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)

• Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment

• Not proficient in English

• Presence of substance abuse in the past one month

• Presence of substance dependence not in remission for the past six months

• Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Unversity of Texas at Dallas	Richardson	Texas	United States	75080

Sponsors and Collaborators

• The University of Texas at Dallas

Investigators

• Principal Investigator: Amy Pinkham, PhD, The University of Texas at Dallas

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 19, 2017

More Information

Publications

None provided.

• Responsible Party: Amy Pinkham, PhD, Associate Professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03370341
• Other Study ID Numbers: 17-127
• First Posted: Dec 12, 2017
• Last Update Posted: Aug 3, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Active Anodal tDCS First, Then Sham Stimulation	Sham tDCS First, Then Active Stimulation
Arm/Group Description	Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham stimulation followed by behavioral testing Intervention: Device: active anodal tDCS	Sham tDCS followed by behavioral testing; Washout (1 week); Active Stimulation followed by behavioral testing Intervention: Device: sham tDCS
Period Title: Overall Study
STARTED	21	20
COMPLETED	21	19
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Active Anodal tDCS First, Then Sham Stimulation	Sham tDCS First, Then Active Stimulation	Total
Arm/Group Description	Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham tDCS followed by behavioral testing Intervention: Device: active anodal tDCS	Sham tDCS followed by behavioral testing; Washout (1 week); Active tDCS followed by behavioral testing Intervention: Device: sham tDCS sham tDCS: sham tDCS with behavioral tasks to assess IA	Total of all reporting groups
Overall Participants	21	20	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.43 (11.05)	39.58 (9.84)	39.5 (10.36)
Sex: Female, Male (Count of Participants)
Female	11 52.4%	6 30%	17 41.5%
Male	10 47.6%	14 70%	24 58.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 28.6%	6 30%	12 29.3%
Not Hispanic or Latino	15 71.4%	14 70%	29 70.7%
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	7 33.3%	11 55%	18 43.9%
White	14 66.7%	9 45%	23 56.1%
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	21 100%	20 100%	41 100%
Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.33 (2.81)	12.34 (1.93)	12.34 (2.41)
Estimated IQ (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	98.95 (11.57)	94.26 (10.01)	96.73 (10.98)

Outcome Measures

1. Primary Outcome

Title	Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation
Description	Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Time Frame	Assessment will be completed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Anodal tDCS	Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	.534 (.068)	.526 (.085)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Anodal tDCS, Sham tDCS
	Comments	The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.56
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation
Description	Social Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA.
Time Frame	Assessment will be completed 30 minutes after completion of the active/sham stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Anodal tDCS	Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing	20 minutes of Sham tDCS followed by behavioral testing
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	.575 (.095)	.562 (.098)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Anodal tDCS, Sham tDCS
	Comments	The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.38
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	3 days after each arm.
Arm/Group Title	Active Anodal tDCS		Sham tDCS
Arm/Group Description	20 minutes of Active anodal tDCS followed by behavioral testing		20 minutes of Sham tDCS followed by behavioral testing
All Cause Mortality
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)
Serious Adverse Events
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Active Anodal tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (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.