N/A
N=41
Stimulating the Brain to Improve Self-Awareness
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03370341 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation — .534; .526 score on a scale — p=.56
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- active anodal tDCS (Device); sham tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas at Dallas
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation |
.534; .526 | .56 |
| SECONDARY Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation |
.575; .562 | .38 |
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).
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)
Data sourced from ClinicalTrials.gov (NCT03370341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.