SchizophreniaICDCNCT02539797

Improving Cognition in Schizophrenia Using tDCS

A study testing tDCS in people with Schizophrenia, run by University of California, Los Angeles 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 55 years
Conditions the study is for: Schizophrenia
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: 37 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Oct 2016
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnostic and Statistical Manual of Mental Disorders (DSM)-V Diagnosis of Schizophrenia
Must understand spoken English sufficiently to comprehend testing procedures
Estimated premorbid intelligence quotient (IQ) > 70 (based on reading ability)
Ongoing care of a Psychiatrist, Psychologist, or other qualified mental health professional

Who cannot join

Metal in cranium
Cardiac lines/pacemaker
Medication pump
Increased intracranial pressure
Lifetime history of serious head injury (LOC > 1 hr.)
Sedatives or Benzodiazepines within 12 hours of testing

Show all 14Show fewer

Clinically significant neurological disease (e.g., seizures)
History of mental retardation or developmental disability
Alcohol or substance dependence in the last 6 months
Alcohol or substance abuse in the last 1 month
Change in medication in past 6 weeks
Change in in living situation in the last 2 months
Inpatient hospitalization in past 3 months
Participation in prior studies involving tDCS

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Improving Cognition in Schizophrenia Using Transcranial Direct Current Stimulation

This study will examine the benefits of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving neurocognitive and social cognitive functions in schizophrenia. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in healthy individuals and several clinical populations. In this pilot study, the investigators will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia. Each participant will arrive for three visits, with approximately one week between each visit. During the first visit, participants will be interviewed about their psychiatric symptoms, personal life experiences, and emotional well being by a specially-trained interviewer. On each of the three visits, participants will receive one of three stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current). Immediately following the stimulation, participants will be asked to complete measures of mental abilities, including tests presented on a computer screen and paper-and-pencil tests. During each visit, participants will also undergo a standard measure of brain activity (EEG) while listening to tones. The first visit will last approximately five hours, and the other two visits will last approximately four hours each. The project will take approximately two years to complete.

Read the detailed description

The investigators plan to recruit 40 individuals diagnosed with Schizophrenia. Participants will range from 18-55 years old. We will select stable, medicated patients who have not been hospitalized nor had any changes in their antipsychotic medications during the previous two months. Participants will not be tested within 12 hours of taking medications that may affect cognition (such as benzodiazepines and anticholinergics). All medications will be recorded. The investigators expect most of the patients to be relatively chronic (mean illness chronicity approximately 15 years, based on previous studies), although we will not select for chronicity.

All participants will provide written informed consent after receiving a full explanation of the procedures according to approvals by the Institutional Review Boards. They will arrive for three visits. In the first visit, they will be consented, complete the diagnostic interview, the rating scales, and will undergo one of three randomly assigned stimulation conditions: 1) anodal tDCS, 2) cathodaltDCS, and 3) sham stimulation. They will also undergo an electroencephalography (EEG) procedure, in order to more directly assess the effect of tDCS on brain function. This visit will take approximately five hours to complete, and breaks will be given as needed. Immediately following stimulation, participants will complete neurocognitive, social cognitive, and EEG measures. There will be two 20-minute stimulation sessions, with a break of one hour between the sessions. After each session, participants will be asked to complete a portion of the basic cognitive, social cognitive, and EEG measures, so that half of the measures will be completed after the first 20 minute stimulation session and the other half will be completed after the second 20 minute stimulation session. The order of administration of the neurocognitive, social cognitive, and EEG measures will be randomized across participants within each group. During the second and third visits, participants will undergo the remaining two stimulation conditions, one randomly assigned condition each visit. These visits will take approximately four hours to complete, and each visit will be separated by at least one week from the previous visit.

Conditions: Schizophrenia
Being tested: tDCS
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDCSDevice
comparing anodal, cathodal, and sham tDCS

Study groups in NCT02539797
Study group	Role	What they receive
tDCS anodal stimulation	Experimental	anodal stimulation Receives: Device: tDCS
tDCS cathodal stimulation	Active comparator	cathodal stimulation Receives: Device: tDCS
Sham stimulation	Sham comparator	Sham stimulation. Termination of electrical stimulation following 30 seconds Receives: Device: tDCS

What is being measured

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

Change From Baseline in Cognition on MCCB
Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.
Measured: baseline and 20 minutes
Change From Baseline in Managing Emotions on MSCEIT
Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.
Measured: baseline and 20 minutes

Timeline

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

Oct 2014Oct 2016

First posted3 Sep 2015 (estimated)
Study startOct 2014
Primary completionOct 2016
Study completionOct 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe 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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539797
Sponsor's protocol ID: 22017
Acronym: ICDC
Status last verified: Feb 2018
First submitted: 26 Aug 2015
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rassovsky Y, Dunn W, Wynn JK, Wu AD, Iacoboni M, Hellemann G, Green MF. Single transcranial direct current stimulation in schizophrenia: Randomized, cross-over study of neurocognition, social cognition, ERPs, and side effects. PLoS One. 2018 May 7;13(5):e0197023. doi: 10.1371/journal.pone.0197023. eCollection 2018.
PubMed 29734347

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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Cognition in Schizophrenia Using Transcranial Direct Current Stimulation
ClinicalTrials.gov ID: NCT02539797
Acronym / sponsor ID: ICDC / 22017
Conditions: Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: Oct 2014 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 7 Mar 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
tDCS anodal stimulation	Experimental	Device: tDCSanodal stimulation
tDCS cathodal stimulation	Active comparator	Device: tDCScathodal stimulation
Sham stimulation	Sham comparator	Device: tDCSSham stimulation. Termination of electrical stimulation following 30 seconds

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Diagnostic and Statistical Manual of Mental Disorders (DSM)-V Diagnosis of Schizophrenia
Must understand spoken English sufficiently to comprehend testing procedures
Estimated premorbid intelligence quotient (IQ) > 70 (based on reading ability)
Ongoing care of a Psychiatrist, Psychologist, or other qualified mental health professional

Key exclusion criteria (14 listed)

Metal in cranium
Cardiac lines/pacemaker
Medication pump
Increased intracranial pressure
Lifetime history of serious head injury (LOC > 1 hr.)

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
tDCScomparing anodal, cathodal, and sham tDCS	Device	Sham stimulation, tDCS anodal stimulation, tDCS cathodal stimulation

Primary outcome

Change From Baseline in Cognition on MCCB
Time frame: baseline and 20 minutes
Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.
Change From Baseline in Managing Emotions on MSCEIT
Time frame: baseline and 20 minutes
Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.

Results and safety

Results posted to the registry on 7 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anodal Cathodal Sham	12	12
Cathodal Sham Anodal	13	12
Sham Anodal Cathodal	13	13

Primary outcome: Change From Baseline in Cognition on MCCB

Time frame: baseline and 20 minutes. Mean (Standard Error). Unit: T-scores

Measure	tDCS Anodal Stimulation n = 37	tDCS Cathodal Stimulation n = 37	Sham Stimulation n = 37
Value	45.0 (1.65)	45.2 (1.65)	45.8 (1.64)

Primary outcome: Change From Baseline in Managing Emotions on MSCEIT

Time frame: baseline and 20 minutes. Mean (Standard Error). Unit: T-scores

Measure	tDCS Anodal Stimulation n = 37	tDCS Cathodal Stimulation n = 37	Sham Stimulation n = 37
Value	36.4 (2.06)	37.7 (2.05)	37.1 (2.05)

Adverse events

Time frame: Following every tDCS administration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS Anodal Stimulation	0 of 37 (0%)	0 of 37 (0%)	Not reported
tDCS Cathodal Stimulation	0 of 37 (0%)	0 of 37 (0%)	Not reported
Sham Stimulation	0 of 37 (0%)	0 of 37 (0%)	Not reported

Limitations and caveats (from the sponsor): The present findings employed a single tDCS administration, which may be insufficient to attain potential therapeutic effects. These findings thus add to the growing body of evidence suggesting the need for basic dose-finding studies in tDCS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29734347Rassovsky Y, Dunn W, Wynn JK, Wu AD, Iacoboni M, Hellemann G, Green MF. Single transcranial direct current stimulation in schizophrenia: Randomized, cross-over study of neurocognition, social cognition, ERPs, and side effects. PLoS One. 2018 May 7;13(5):e0197023. doi: 10.1371/journal.pone.0197023. eCollection 2018.

Related trials for Schizophrenia

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A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
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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.

Yuri Rassovsky, PhD principal investigator

University of California, Los Angeles

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 Schizophrenia, run by University of California, Los Angeles 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 4 inclusion and 14 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 7 Mar 2018. 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 7 Mar 2018). 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 From Baseline in Cognition on MCCB (time frame: baseline and 20 minutes). The study lists 2 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 NCT02539797, which also lists 1 linked publication.

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 7 Mar 2018.