Stimulating the Brain to Improve Self-Awareness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03370341|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Device: active anodal tDCS Device: sham tDCS||Not Applicable|
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|
|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|
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
- 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.
- 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.
- 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.
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
|Contact: Amy Pinkham, PhDemail@example.com|
|United States, Texas|
|The Unversity of Texas at Dallas||Recruiting|
|Richardson, Texas, United States, 75080|
|Contact: Emily Bass, BS 972-883-4637 firstname.lastname@example.org|
|Principal Investigator:||Amy Pinkham, PhD||The University of Texas at Dallas|