SchizophreniaNCT03208036
Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
A study testing TDCS, Cognitive Remediation and Bridging Group in people with Schizophrenia and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Schizo Affective Disorder
- What is being tested?
- TDCS, Cognitive Remediation and Bridging Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
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
- Being tested
- TDCS, Sham Stimulation, Cognitive Remediation, Bridging Group
- Keywords
- schizophrenia, tdcs, working memory, cognitive remediation, cognition, serious mental illness
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCSDevice
Also called Transcranial Direct Current Stimulation
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 StimulationDevice
Also called Sham
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 RemediationBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TDCS | Experimental | TDCS offered concurrent with working memory focused cognitive training Receives: Device: TDCS; Behavioral: Cognitive Remediation; Behavioral: Bridging Group |
| Sham | Sham comparator | Sham stimulation offered concurrent with working memory focused cognitive training Receives: Device: Sham Stimulation; Behavioral: Cognitive Remediation; Behavioral: Bridging Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Total score at Baseline, 4 months, and 5.5 months
Secondary outcomes (6)
First-Episode Social Functioning Scale Actual Performance Total Score
Total score summed from Actual Performance subscales 1-5. This is a self-report measure of social and community functioning in the past 3 months. Scores reflect the frequency with which participants report engaging in a behavior. Total score ranges from 20-80, with a higher score indicating better social functioning in the community.
Measured: Total score at Baseline, 4 months, and 5.5 months
Novel N-Back Task D Prime Score
This is a working memory task. The number and picture n-back tasks are novel versions of the training tasks used in this protocol. D-prime, a measure of response accuracy that takes into account hit rate and false alarm rate was used to measure overall performance on each task. This measure of performance accuracy ranges from -4.546 to 4.546, with a higher, positive score indicating better performance. A score of 0 indicates chance level performance. D prime scores from the number and picture task were average to create one d prime measure that reflects performance on novel, untrained n-back measures. Improvement on these tasks would indicate generalization of learning from the trained tasks.
Measured: D prime at Baseline, 4 months, and 5.5 months
Complex Span Task Z-score
This is a working memory task. This measure is an indicator of whether participants were able to improve on a task procedurally similar to the training tasks. Rotation and Reading complex span tasks are novel versions of training tasks. A z-score was used to measure performance on each task. Z-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. Z-scores from the Rotation and Reading span tasks were averaged to create one measure of working memory. Improvement on this task would indicate generalization of learning from the training.
Measured: 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
Two subscales from the MATRICS Consensus Cognitive Battery, the Processing Speed subscale and the Reasoning and Problem-Solving subscale, were averaged to create a composite that reflects performance on cognitive functions closely related to working memory. Performance on each subscale was measured with a T-score. T-scores range from 0-100. A score of 50 reflects the population mean, with a standard deviation of 10. On each subscale, a higher score indicated better performance in the cognitive domain. Improvement on this composite T-score would indicate generalization of training gains to untrained cognitive domains.
Measured: T-score at Baseline, 4 months, and 5.5 months
Brief Psychiatric Rating Scale Total Score
This is a 24-item measure of psychiatric symptom severity. Each item is rated on a 1-7 scale, with a higher score indicating that the symptom is more severe. Brief Psychiatric Rating Scale Total score can range from 24-168, with a higher score indicating the presence of more severe psychiatric symptoms.
Measured: Total score at Baseline, 4 months, and 5.5 months
Brief Negative Symptom Severity Scale Total Score
This is a 13-item scale that measures the severity of negative symptoms. Each item is rated from 0-6, with a higher score indicating that the symptom is more severe. Brief Negative Symptom Severity Scale Total score can range from 0 to 78, with a higher score indicating more severe negative symptoms
Measured: Total score at Baseline, 4 months, and 5.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start15 Jul 2018
- Primary completion1 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tasha M Nienow, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208036
- Sponsor's protocol ID
- D0180-R
- Other IDs
- I01RX000180
- Status last verified
- Nov 2022
- First submitted
- 30 Jun 2017
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03208036
- Acronym / sponsor ID
- D0180-R
- Conditions
- Schizophrenia, Bipolar Disorder, Schizo Affective Disorder
- Keywords
- schizophrenia, tdcs, working memory, cognitive remediation, cognition, serious mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TDCS | Experimental | Device: TDCS, Behavioral: Cognitive Remediation, Behavioral: Bridging GroupTDCS offered concurrent with working memory focused cognitive training |
| Sham | Sham comparator | Device: Sham Stimulation, Behavioral: Cognitive Remediation, Behavioral: Bridging GroupSham stimulation offered concurrent with working memory focused cognitive training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDCSAlso: Transcranial Direct Current Stimulation1 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 | TDCS |
| Sham StimulationAlso: ShamParticipants 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 | Device | Sham |
| Cognitive RemediationParticipants 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. | Behavioural | Sham, TDCS |
| Bridging GroupParticipants 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. | Behavioural | Sham, TDCS |
Primary outcome
Working Memory Capacity Composite Score
Time frame: Total score at Baseline, 4 months, and 5.5 months
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
Goal Maintenance Composite Score
Time frame: D Prime at Baseline, 4 months, and 5.5 months
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.
Interference Control Composite Score
Time frame: Z-score at Baseline, 4 months, and 5.5 months
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.
The University of California San Diego Performance-Based Skills Assessment Total Score
Time frame: Total score at Baseline, 4 months, and 5.5 months
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.
6 secondary outcomes
First-Episode Social Functioning Scale Actual Performance Total Score
Time frame: Total score at Baseline, 4 months, and 5.5 months
Novel N-Back Task D Prime Score
Time frame: D prime at Baseline, 4 months, and 5.5 months
Complex Span Task Z-score
Time frame: 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
Time frame: T-score at Baseline, 4 months, and 5.5 months
Brief Psychiatric Rating Scale Total Score
Time frame: Total score at Baseline, 4 months, and 5.5 months
Brief Negative Symptom Severity Scale Total Score
Time frame: Total score at Baseline, 4 months, and 5.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasha M Nienow, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDCS, Cognitive Remediation and Bridging Group in people with Schizophrenia and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory Capacity Composite Score (time frame: Total score at Baseline, 4 months, and 5.5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.