Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
NCT ID: NCT03208036
Last Updated: 2022-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2018-07-15
2022-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TDCS
TDCS offered concurrent with working memory focused cognitive training
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
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.
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.
Sham
Sham stimulation offered concurrent with working memory focused cognitive training
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
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.
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.
Interventions
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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
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
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* defined as not severely depressed or acutely manic and no hospitalizations or antipsychotic medication changes in the four weeks prior to enrollment
Exclusion Criteria
* Met criteria for a mild alcohol or substance use disorder in the last month
* A history of head injury or neurological disease that has compromised cognitive functioning
* Ability to speak English is not sufficient to understand study procedures
* Diagnosis of learning disability, mental retardation, or pervasive developmental disorder
* Diagnosis of a medical condition that is incompatible with tDCS procedures
* Participant does not demonstrate understanding of study procedures during the consent process
* A documented history of behavioral problems that prevent participation in a group intervention
* Participated in a study of tDCS or cognitive remediation in the previous 12 months
18 Years
65 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Tasha M Nienow, PhD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Locations
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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D0180-R
Identifier Type: -
Identifier Source: org_study_id