Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
Condition: Schizophrenia; Bipolar Disorder; Schizo Affective Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Development of interventions that can effectively target and remediate the cognitive and
      functional impairment associated with serious mental illness is a treatment priority.
      Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation
      technique that is capable of stimulating brain activity to facilitate learning. The primary
      objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive
      remediation and tDCS, as a cognitively enhancing intervention. This study is designed to test
      the hypotheses that cognitive remediation paired with tDCS will be more efficacious than
      cognitive remediation delivered with sham stimulation and that intervention-induced cognitive
      change will be sustainable.

      To examine the incremental benefit of pairing tDCS with cognitive remediation, clinically
      stable outpatients between the ages of 18-65 who have a diagnosis of schizophrenia,
      schizoaffective disorder, or bipolar disorder will be enrolled in a double-blind,
      double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1
      ratio to receive either tDCS or sham stimulation concurrent with working memory focused
      cognitive remediation. Training will be offered to participants in a small group format.
      Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training
      session will last 2 hours. One hour will be spent completing cognitive exercises that require
      working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with
      the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation
      will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will
      be placed in the contralateral supraorbital position. Upon completion of working memory
      training, participants will transition to a 45-minute bridging group focus on application of
      cognitive skills in everyday life. To assess intervention-induced change, working memory,
      other aspects of cognition, functional capacity, community functioning, and symptom severity
      will be assessed pre- and post-intervention. Sustainability of intervention-induced change
      will be assessed with an assessment session 6 weeks post-intervention. Mixed effect, repeated
      measure ANOVAS will be used to analyze intervention-induced change.
    


Intervention name(s): TDCS; Sham Stimulation; Cognitive Remediation; Bridging Group
Intervention type(s): Device; Device; Behavioral; Behavioral
Intervention description(s): 1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes; Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition; Participants complete 60 minutes of computer-based cognitive training. All tasks are adaptable in terms of difficulty and require working memory skills. Sessions always begin with N-back and complex span tasks completed concurrent with tDCS or sham stimulation. Other tasks selected from Happy Neuron software and experimental working memory tasks are used throughout the protocol.; Participants complete 45 minutes of activities and discussion to practice engaging cognitive skills through performance of everyday activities and to learn strategies to use cognitive abilities most effectively. Curriculum generated from Action-based Cognitive Remediation and Compensatory Cognitive Training intervention manuals.
Other intervention name(s): Transcranial Direct Current Stimulation; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, double-baseline, sham-controlled study in which participants are randomized to receive either tDCS or sham stimulation concurrent with cognitive training.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; tdcs; working memory; cognitive remediation; cognition; serious mental illness