Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
2 other identifiers
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Jul 2018
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedStudy Start
First participant enrolled
July 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedResults Posted
Study results publicly available
December 21, 2022
CompletedDecember 21, 2022
November 1, 2022
3.4 years
June 30, 2017
September 26, 2022
November 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Working Memory Capacity Composite Score
This is a measure of one core component of working memory. Proportion correct average from Change Detection and Change Localization Tasks. Score ranges from 0.00 to 1.00, with a higher score indicating better performance
Total score at Baseline, 4 months, and 5.5 months
Goal Maintenance Composite Score
This is a measure of one core component of working memory. Performance on the Dot Pattern Expectancy Task and AX-Continuous Performance Task was measured with d prime. D Prime is a measure of response accuracy that takes into account both hit rate and false alarm rate. This measure of response accuracy ranges from -4.546 to 4.546, with a higher score indicating better performance. A score of 0 indicates chance level performance. D prime scores reflecting overall performance on the Dot Pattern Expectancy Task and the AX-Continuous Performance Task were averaged. The resulting d prime score reflects performance on the goal maintenance component of working memory.
D Prime at Baseline, 4 months, and 5.5 months
Interference Control Composite Score
This is a measure of one core component of working memory. Performance on Rotation and Reading Complex Span Tasks was measured with z-scores. Scores range from -3 to 3, with a higher positive score indicating better performance. A score of 0 represents the sample mean at the baseline assessment. The z-scores reflecting overall performance on Rotation and Reading Span Tasks were averaged to create one z-score that reflects performance on the interference control component of working memory.
Z-score at Baseline, 4 months, and 5.5 months
The University of California San Diego Performance-Based Skills Assessment Total Score
This is a performance-based measure of functional capacity to perform activities of daily living. This measure has two scales, measuring financial and communication skills. The two scales are summed to create a total score. The Total score ranges from 0-100, with a higher score indicating better performance.
Total score at Baseline, 4 months, and 5.5 months
Secondary Outcomes (6)
First-Episode Social Functioning Scale Actual Performance Total Score
Total score at Baseline, 4 months, and 5.5 months
Novel N-Back Task D Prime Score
D prime at Baseline, 4 months, and 5.5 months
Complex Span Task Z-score
Z-score at Baseline, 4 months, and 5.5 months
MATRICS Consensus Cognitive Battery Processing Speed Subscale and the Reasoning and Problem-Solving Subscale T-score Average
T-score at Baseline, 4 months, and 5.5 months
Brief Psychiatric Rating Scale Total Score
Total score at Baseline, 4 months, and 5.5 months
- +1 more secondary outcomes
Study Arms (2)
TDCS
EXPERIMENTALTDCS offered concurrent with working memory focused cognitive training
Sham
SHAM COMPARATORSham stimulation offered concurrent with working memory focused cognitive training
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants are eligible for the study if they have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder and are clinically stable at the time of enrollment
- defined as not severely depressed or acutely manic and no hospitalizations or antipsychotic medication changes in the four weeks prior to enrollment
You may not qualify if:
- Met criteria for a severe alcohol or substance use disorder in the last 6 months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tasha Nienow
- Organization
- Minneapolis VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Tasha M Nienow, PhD
Minneapolis VA Health Care System, Minneapolis, MN
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants, interventionists, and the outcome assessors will be blind to participant condition. The neuromodulation device can be pre-programmed to deliver either tDCS or sham stimulation when an ID code is entered. The study personnel randomizing participants and programming the equipment will not have contact with participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 5, 2017
Study Start
July 15, 2018
Primary Completion
December 1, 2021
Study Completion
February 28, 2022
Last Updated
December 21, 2022
Results First Posted
December 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available at study closure and accessible for 6 years.
- Access Criteria
- When a request for data is received, an agreement will be set up and approved by the local facility before data is released.
A de-identified, anonymized dataset will be created and shared. Final data set will be made available upon written request. In order to fulfill requests, I will ensure that all data storage locations are kept current in the Minneapolis VAHCS Data Inventory database, and I will store all study research records and data for a minimum of 6 fiscal years post study closure.