Stimulating the Brain to Improve Self-Awareness

Schizophrenia Clinical Trial

Official title:

Stimulating the Brain to Improve Self-Awareness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370341
• Other study ID #: 17-127
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2023
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Device:
• active anodal tDCS
active anodal tDCS with behavioral tasks to assess IA
• sham tDCS
sham tDCS with behavioral tasks to assess IA

Locations

Country	Name	City	State
United States	The Unversity of Texas at Dallas	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment will be completed 30 minutes after completion of the active/sham stimulation
Secondary	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.	Assessment will be completed 30 minutes after completion of the active/sham stimulation