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Stimulating the Brain to Improve Self-Awareness

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ClinicalTrials.gov Identifier: NCT03370341
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Amy Pinkham, The University of Texas at Dallas

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).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Device: active anodal tDCS Device: sham tDCS Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Stimulating the Brain to Improve Self-Awareness
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Active anodal tDCS
Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS
Device: active anodal tDCS
active anodal tDCS with behavioral tasks to assess IA

Sham Comparator: Sham tDCS
Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS
Device: sham tDCS
sham tDCS with behavioral tasks to assess IA




Primary Outcome Measures :
  1. Neurocognitive Introspective Accuracy [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    Neurocognitive Introspective Accuracy assessed with the Wisconsin Card Sorting Task.


Secondary Outcome Measures :
  1. Neurocognitive Introspective Accuracy [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    Neurocognitive Introspective Accuracy assessed with the MATRICS Consensus Cognitive Battery.

  2. Social Cognitive Introspective Accuracy [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    Social Cognitive Introspective Accuracy assessed with emotion recognition tasks.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370341


Contacts
Contact: Amy Pinkham, PhD 972-883-4462 amy.pinkham@utdallas.edu

Locations
United States, Texas
The Unversity of Texas at Dallas Recruiting
Richardson, Texas, United States, 75080
Contact: Emily Bass, BS    972-883-4637    emily.bass@utdallas.edu   
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
Principal Investigator: Amy Pinkham, PhD The University of Texas at Dallas

Responsible Party: Amy Pinkham, Associate Professor, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03370341     History of Changes
Other Study ID Numbers: 17-127
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders