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Stimulating the Brain to Improve Self-Awareness

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active anodal tDCS
sham tDCS
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Unversity of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active anodal tDCS first, then Sham tDCS

Sham tDCS first, then Active anodal tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neurocognitive Introspective Accuracy for Active vs. 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

Social Cognitive Introspective Accuracy for Active vs. 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.

Full Information

First Posted
December 7, 2017
Last Updated
March 20, 2023
Sponsor
The University of Texas at Dallas
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1. Study Identification

Unique Protocol Identification Number
NCT03370341
Brief Title
Stimulating the Brain to Improve Self-Awareness
Official Title
Stimulating the Brain to Improve Self-Awareness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active anodal tDCS first, then Sham tDCS
Arm Type
Experimental
Arm Description
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
Arm Title
Sham tDCS first, then Active anodal tDCS
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
active anodal tDCS
Intervention Description
active anodal tDCS with behavioral tasks to assess IA
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
sham tDCS with behavioral tasks to assess IA
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Pinkham, PhD
Organizational Affiliation
The University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Unversity of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stimulating the Brain to Improve Self-Awareness

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