Stimulating the Brain to Improve Self-Awareness

NCT03370341 | Completed Results FDA Device

• 1 other identifier: 17-127
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation

  Assessment will be completed 30 minutes after completion of the active/sham stimulation

Study Arms (2)

Active anodal tDCS first, then Sham tDCS

EXPERIMENTAL

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; Device: sham tDCS

Sham tDCS first, then Active anodal tDCS

SHAM COMPARATOR

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; Device: sham tDCS

Interventions

active anodal tDCS DEVICE

active anodal tDCS with behavioral tasks to assess IA

Active anodal tDCS first, then Sham tDCS; Sham tDCS first, then Active anodal tDCS

sham tDCS DEVICE

sham tDCS with behavioral tasks to assess IA

Active anodal tDCS first, then Sham tDCS; Sham tDCS first, then Active anodal tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The Unversity of Texas at Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Amy Pinkham
• Organization: The University of Texas at Dallas

amy.pinkham@utdallas.edu

(972) 883-4462

Study Officials

• Amy Pinkham, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 22, 2023
• Results First Posted: August 3, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)