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Restoration of Cognitive Function With TDCS and Training in Schizophrenia

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: NCT03208036
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 5, 2017
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE July 15, 2018
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
  • Working Memory Capacity Composite Score [ Time Frame: Change from Baseline Working Memory Capacity at 4 months ]
    Working Memory Domain Age and Gender Corrected T-Scores on MATRICS Consensus Cognitive Battery
  • Goal Maintenance Composite Score [ Time Frame: Change from Baseline Goal Maintenance at 4 months ]
    Average of MATRICS Consensus Cognitive Battery Attention Domain Age and Gender Corrected T-score and performance measured with d prime on the Dot Pattern Expectancy Task
  • Interference Control Composite Score [ Time Frame: Change from Baseline Interference Control at 4 months ]
    Average of sensitivity measures on the Sternberg Item Recognition Paradigm and the Suppress Task
  • The University of California San Diego Performance-Based Skills Assessment [ Time Frame: Change from Baseline T-score on Adaptive Skills test at 4 months ]
    T-score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
  • First-Episode Social Functioning Scale [ Time Frame: Change from Baseline Social Functioning at 4 months ]
    Total score
  • N-Back Performance [ Time Frame: Change from Baseline N-back performance at 4 months ]
    D-prime on N-back task
  • Complex Span Task [ Time Frame: Change from Baseline Complex Span Task performance at 4 months ]
    Total Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restoration of Cognitive Function With TDCS and Training in Schizophrenia
Official Title  ICMJE Restoration of Cognitive Function With TDCS and Training in Schizophrenia
Brief Summary

Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with schizophrenia 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 address four questions. Is cognitive remediation paired with tDCS more efficacious than cognitive remediation delivered with sham stimulation? Is it possible to predict responsiveness to the intervention? Is intervention-induced cognitive change sustainable? Are there barriers to implementing this intervention in clinical practice?

To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110 clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia or schizoaffective 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 30-minute discussion group. The discussion will focus on application of cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will be described and practiced. Participant experience with aspects of the training will be monitored with self-report measures of motivation, mood, and physical reactions. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, and community functioning will be assessed pre- and post-intervention. Cognitive outcomes will be assessed with training tasks as well as tasks that are unfamiliar to participants. A performance-based measure will be used to assess functional capacity for everyday living skills and a self-report instrument will be used to assess community functioning. Potential confounds such as symptom severity, medication changes, outside treatment hours, and significant life stressors will be assessed individually every 2 weeks during the intervention phase of the study. Sustainability of intervention-induced change will be assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in performance during the first 12 training sessions on two working memory training tasks, a n-back task and a complex span task, will be used to determine if early response to treatment is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to analyze intervention-induced change. Regression analyses will be conducted to identify predictors of treatment response.

Achieving the proposed objectives will yield important information about the efficacy, durability, and efficiency of a novel pairing of cognitively enhancing interventions. Findings will inform treatment development for patients with schizophrenia as well for patients with other cognitively compromising illnesses.

Detailed Description human subjects recruitment is suspended due to COVID-19 virus pandemic
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
    Other Name: Transcranial Direct Current Stimulation
  • 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
    Other Name: Sham
Study Arms  ICMJE
  • Experimental: TDCS
    TDCS offered concurrent with working memory focused cognitive training
    Intervention: Device: TDCS
  • Sham Comparator: Sham
    Sham stimulation offered concurrent with working memory focused cognitive training
    Intervention: Device: Sham Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2017)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants are eligible for the study if they have a diagnosis of schizophrenia or schizoaffective 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tasha M Nienow, PhD (612) 467-1004 Tasha.Nienow@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03208036
Other Study ID Numbers  ICMJE D0180-R
I01RX000180 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tasha Marie Nienow, PhD Minneapolis VA Health Care System, Minneapolis, MN
PRS Account VA Office of Research and Development
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP