PsychosisNCT02085421

Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

A study testing tDCS in people with Psychosis, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Psychosis
What is being tested?: tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2019to 9 Feb 2023
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Meet diagnostic criteria for schizophrenia or schizoaffective disorder
Are age 18-64
Fluent in written and spoken English
Have an outpatient status of at least 1 month prior to participation
Has been on a stable dose of psychiatric medication for at least one month prior to participation

Who cannot join

History of seizures or epilepsy
Metallic cranial plates, screws, or implanted devices
History of craniotomy
History of stroke
History of eczema on scalp
Pre-existing sores or lesions at sites of tDCS electrode placement

Show all 9Show fewer

Non removable facial piercings
Current or possibility of current pregnancy
Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55454

Other trials in United States

About this study

The proposed pilot study is a randomized controlled study to assess effectiveness of transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The investigators hypothesis is that the use of tDCS will enhance the improvement seen with cognitive remediation therapy.

Read the detailed description

The proposed pilot study is a randomized controlled study to assess effectiveness of tDCS to enhance cognitive remediation therapy in patients with psychotic disorders. All patients will participate in cognitive remediation therapy (CRT). After initial consent form has been signed, all participants will undergo various neurocognitive and psychological assessments including the Brief Assessment of Cognition in Schizophrenia (BACS), an EEG, and several other tasks/assessments. Participants will then complete 2-4 CRT sessions per week, each lasting approximately one hour, for a total of 10 sessions. The CRT will use a commercially available PositScience software package. Each CRT session involves an in-session assessment of skill acquisition, as collected by commercially available CRT software.

Patients will be randomized into two arms: active tDCS vs. sham tDCS. The tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) each CRT session. The anode will be placed over left DLPFC (dorsolateral prefrontal cortex) at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area (Fp2). This placement is consistent with previous protocols targeting working memory. Both active and sham conditions will have identical electrode placement.

After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. Once logged in to CRT software they will be instructed to begin the session.

The tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) for the first 20 minutes of each CRT session in the active condition. In the sham condition, tDCS will be ramped up to 1-2 mA via two saline soaked electrode sponges (3 cm x 4.5 cm) over the first 30 seconds of each CRT session and then turned off.

Participants will complete the hour long CRT session. The software program instructs the patient when the end of the session has been reached.

At the completion of the 10 sessions of CRT, both active and sham tDCS patients will repeat the the same assessments from the beginning, including the BACS, another EEG, and several other tasks/assessments. Patients will also be asked to return for a 1-month follow-up where most of the same tasks/assessments are completed.

The consent and baseline assessments take about 8 hours in total and can be split up into 2-4 appointments. Each of the 10 training sessions lasts approximately 1 hour for a total of 10 hours of training. The post-training assessments take about 6 hours and can be split up into 2-3 appointments. The 1-month follow-up takes approxmately 3.5 hours and can be completed in 1-2 appointments. The total time commitment for this study is approximately 28-32 hours.

Conditions: Psychosis
Being tested: tDCS
Keywords: tdcs, neuromodulation, CRT, psychosis, schizophrenia
Medical subject headings: Psychotic Disorders, Creatine deficiency, X-linked, Schizophrenia

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
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that has been shown to enhance learning. tDCS is applied with current intensity of 1-2 mA of direct current and can be applied both before and during each cognitive remediation treatment session. Two saline soaked electrode sponges will be applied to the scalp.

Study groups in NCT02085421
Study group	Role	What they receive
Active tDCS	Active comparator	The active tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) for the first 20 minutes of each CRT session in the active condition. Receives: Device: tDCS
Sham tDCS	Sham comparator	In the sham condition, tDCS will be ramped up to 1-2 mA via two saline soaked electrode sponges (3 cm x 4.5 cm) over the first 30 seconds of each CRT session and then turned off. Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training
Clinician-administered neurocognitive battery that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.
Brief Assessment of Cognition in Schizophrenia (BACS) - post training composite z-score range Arm 1 = -2.46 - 2.24 range Arm 2 = -7.67 - 0.83 Higher scores represent better cognitive performance. The BAC APP composite z-score is calculated as the sum of the subscale z-scores (i.e., verbal memory, digit sequencing, verbal fluency, symbol coding, and tower of london), adjusted by participant age and sex.
The primary outcome measure from the BACS is a composite z score, with 0 representing the population mean, normed by age and gender.
Measured: Baseline, 3-5 weeks
Change in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) From Baseline to Post-Training
The VRFCAT is a performance-based functional capacity measure and the 'total recipes accessed' variable represents one component of the full measure. Using a realistic virtual reality environment, the VRFCAT assesses a subject's ability to complete instrumental activities associated with a shopping trip. This provides an estimate of performance on everyday functional tasks. The summary measures include: total time (seconds), total errors, total progressions, total bus schedule checks, total recipe checks. There is no combined total score for this Tool. The minimum number of recipe checks is 0 and there is no maximum number of recipe checks for this task. A higher score on the summary measure 'total recipe checks' indicates worse performance. This means that the higher the number of times a subject consults the reference materials (i.e., recipe), the worse the performance. Based o
Measured: Baseline, 3-5 weeks
Change in the D-prime Score of the N-Back Working Memory Test From Baseline to Post-Training
N-back testing is a performance task used to assess working memory. In this task, pairs of numbers are presented on a computer screen, and participant are instructed to press a button whenever the pair of numbers corresponds to the pair of numbers presented two trials before (2-back). Number of hits and number of false alarms are used to calculate d-prime, the primary outcome. Depending on the number of trials completed, the range of d-prime is expected to be from -4.46 (0 hits, 80 FA) to +4.46 (20 hits, 0 FA), based on the literature. In our study, hits ranged from 3-56 and false alarms ranged from 1-146, therefore d-prime ranged from -0.42-4.02 in the full sample for the 2-back condition. A lower score on d-prime indicates worse performance.
Measured: Baseline, 3-5 weeks

Secondary outcomes (2)

N-Back - Post Training 2-back Number of Hits Provided Here
reflects the number of correct responses and the unit is the number of trials. Number of hits and number of false alarms are used to calculate d-prime, the primary outcome.
Measured: 3-5 weeks
N-Back - Post Training 2-back Number of False Alarms Provided Here
reflects the number of times the participant incorrectly indicates that there is a match (when there is not) and the unit is the number of trials. Number of hits and number of false alarms are used to calculate d-prime, the primary outcome.
Measured: 3-5weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20199 Feb 2023

First posted12 Mar 2014 (estimated)
Study start14 Mar 2019
Primary completion9 Feb 2023
Study completion9 Feb 2023

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 PsychosisStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe 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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02085421
Sponsor's protocol ID: PSYCH-2016-23547
Status last verified: Feb 2025
First submitted: 6 Mar 2014
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
ClinicalTrials.gov ID: NCT02085421
Acronym / sponsor ID: PSYCH-2016-23547
Conditions: Psychosis
Keywords: tdcs, neuromodulation, CRT, psychosis, schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 14 Mar 2019 (actual)
Primary completion: 9 Feb 2023 (actual)
Study completion: 9 Feb 2023 (actual)
First posted: 12 Mar 2014 (estimated)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will complete the hour long CRT session. The software program instructs the patient when the end of the session has been reached.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tDCS	Active comparator	Device: tDCSThe active tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) for the first 20 minutes of each CRT session in the active condition.
Sham tDCS	Sham comparator	Device: tDCSIn the sham condition, tDCS will be ramped up to 1-2 mA via two saline soaked electrode sponges (3 cm x 4.5 cm) over the first 30 seconds of each CRT session and then turned off.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Meet diagnostic criteria for schizophrenia or schizoaffective disorder
Are age 18-64
Fluent in written and spoken English
Have an outpatient status of at least 1 month prior to participation
Has been on a stable dose of psychiatric medication for at least one month prior to participation

Key exclusion criteria (9 listed)

History of seizures or epilepsy
Metallic cranial plates, screws, or implanted devices
History of craniotomy
History of stroke
History of eczema on scalp

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 stimulationTranscranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that has been shown to enhance learning. tDCS is applied with current intensity of 1-2 mA of direct current and can be applied both before and during each cognitive remediation treatment session. Two saline soaked electrode sponges will be applied to the scalp.	Device	Active tDCS, Sham tDCS

Primary outcome

Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training
Time frame: Baseline, 3-5 weeks
Clinician-administered neurocognitive battery that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. Brief Assessment of Cognition in Schizophrenia (BACS) - post training composite z-score range Arm 1 = -2.46 - 2.24 range Arm 2 = -7.67 - 0.83 Higher scores represent better cognitive performance. The BAC APP composite z-score is calculated as the sum of the subscale z-scores (i.e., verbal memory, digit sequencing, verbal fluency, symbol coding, and tower of london), adjusted by participant age and sex. The primary outcome measure from the BACS is a composite z score, with 0 representing the population mean, normed by age and gender.
Change in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) From Baseline to Post-Training
Time frame: Baseline, 3-5 weeks
The VRFCAT is a performance-based functional capacity measure and the 'total recipes accessed' variable represents one component of the full measure. Using a realistic virtual reality environment, the VRFCAT assesses a subject's ability to complete instrumental activities associated with a shopping trip. This provides an estimate of performance on everyday functional tasks. The summary measures include: total time (seconds), total errors, total progressions, total bus schedule checks, total recipe checks. There is no combined total score for this Tool. The minimum number of recipe checks is 0 and there is no maximum number of recipe checks for this task. A higher score on the summary measure 'total recipe checks' indicates worse performance. This means that the higher the number of times a subject consults the reference materials (i.e., recipe), the worse the performance. Based o
Change in the D-prime Score of the N-Back Working Memory Test From Baseline to Post-Training
Time frame: Baseline, 3-5 weeks
N-back testing is a performance task used to assess working memory. In this task, pairs of numbers are presented on a computer screen, and participant are instructed to press a button whenever the pair of numbers corresponds to the pair of numbers presented two trials before (2-back). Number of hits and number of false alarms are used to calculate d-prime, the primary outcome. Depending on the number of trials completed, the range of d-prime is expected to be from -4.46 (0 hits, 80 FA) to +4.46 (20 hits, 0 FA), based on the literature. In our study, hits ranged from 3-56 and false alarms ranged from 1-146, therefore d-prime ranged from -0.42-4.02 in the full sample for the 2-back condition. A lower score on d-prime indicates worse performance.

2 secondary outcomes

N-Back - Post Training 2-back Number of Hits Provided Here
Time frame: 3-5 weeks
N-Back - Post Training 2-back Number of False Alarms Provided Here
Time frame: 3-5weeks

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS	18	13
Sham tDCS	15	13

Primary outcome: Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training

Time frame: Baseline, 3-5 weeks. Mean (Standard Deviation). Unit: z-score

Measure	Active tDCS n = 13	Sham tDCS n = 13
Value	-0.67 (1.17)	-1.68 (2.33)

Primary outcome: Change in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) From Baseline to Post-Training

Time frame: Baseline, 3-5 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Active tDCS n = 6	Sham tDCS n = 4
Value	12.67 (1.97)	11 (2.94)

Primary outcome: Change in the D-prime Score of the N-Back Working Memory Test From Baseline to Post-Training

Time frame: Baseline, 3-5 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Active tDCS n = 8	Sham tDCS n = 8
Value	1.99 (1.12)	1.42 (1.09)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3-5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
Sham tDCS	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ian S Ramsay, PhD principal investigator

University of Minnesota

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 in people with Psychosis, run by University of Minnesota 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 5 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 12 Mar 2025. 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 12 Mar 2025). 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?

Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training (time frame: Baseline, 3-5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02085421.

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 12 Mar 2025.