NCT03208036

Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Bipolar Disorder
• Schizo Affective Disorder

Interventions

Type	Name	Description
DEVICE	TDCS	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
DEVICE	Sham Stimulation	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
BEHAVIORAL	Cognitive Remediation	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.
BEHAVIORAL	Bridging Group	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.

Timeline

• Start date: 2018-07-15
• Primary completion: 2021-12-01
• Completion: 2022-02-28
• First posted: 2017-07-05
• Last updated: 2022-12-21
• Results posted: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study