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Completed

NCT Number: NCT03370341

Stimulating the Brain to Improve Self-Awareness

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Unversity of Texas at Dallas

Richardson, Texas, 75080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active anodal tDCS

Device

active anodal tDCS with behavioral tasks to assess IA

Sham tDCS

Device

sham tDCS with behavioral tasks to assess IA

Primary outcomes

  1. Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation

    Time frame: 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 outcomes

  1. Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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