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SchizophreniaNCT01971073

Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia

A study testing transcranial direct current stimulation in people with Schizophrenia, run by Bar-Ilan University, Israel at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant responses and to adopt relevant responses instead. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIsrael
Study dates
Jan 2015to 7 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • must be 18 years old or above.
  • Clinical diagnosis of schizophrenia or schizoaffective disorder
  • must be with a stable mental status as demonstrated by a stable Positive and -Negative Symptom Score (PANSS) score over a period of 2 weeks.
  • must have no medication changes in the 2 weeks prior to obtaining informed consent.
  • must be able to give informed consent for the trial.

Who cannot join

  • Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  • Pregnant or breast-feeding.
  • current DSM-V substance or alcohol abuse.
  • Concurrent delirium
  • mental retardation
  • drug-induced psychosis
  • history of clinically significant brain trauma documented by CT or MRI.
  • epilepsy or had seizures 6 months prior the beginning of the study

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

About this study

A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant responses and to adopt relevant responses instead. The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche \& Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.

Read the detailed description

A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant information and to adopt relevant responses instead. This ability is a basic skill which is essential to maintain a normal well-adjusted life. We need to suppress distracting information in order to focus attention, to suppress irrelevant cues in order to retrieve particular memories, and to suppress habitual responses in order to make adaptive choices (Dillon \& Pizzagalli, 2007). The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche \& Paulus, 2001; Nitsche et al., 2003, 2004; Antal et al., 2004). The aim of this study is to test whether anodal and cathodal tDCS differentially modify performance on several cognitive tasks when applied to the left/right dorsolateral prefrontal cortex (DLPFC).

Sixty patients will be divided into four groups: 1) 15 schizophrenic subjects in a tDCS treatment group; 2) 15 schizophrenic subjects in a sham tDCS group; 3) 15 healthy subjects in a tDCS treatment group; 4) 15 healthy subjects in a sham tDCS group. All participants will complete baseline tests including an n-back test, the Hayling test and metaphoric comprehension test. The schizophrenic subjects only, will complete a bank of cognitive tests as a baseline (MATRICS Consensus Cognitive Battery (MCCB). The first meeting for the schizophrenic subjects only will be used to determine the best stimulation area (right/left DLPFC) and type (anodal/ cathodal). Schizophrenic subjects in both the treatment and the control groups will undergo six treatment sessions in total. The cognitive tests will be given to all participants once again at the end of the study. In order to evaluate improvement between the pre-test and the post-test, differences in reaction times and error rate will be calculated for each participant.

This study is important for few reasons. First, this study focus on the difficulty of suppressing irrelevant information, executive function ability essential to leading a normal life. Special populations, and specifically people with schizophrenia, have difficulty suppressing irrelevant information, and a correlation has been noted between this characteristic and weak executive functioning capabilities. In this study we evaluate the potential of minimizing these difficulties through use of tDCS. This particular tool was chosen for the study because it is easy to use, non-invasive, and painless. Research has shown that tDCS stimulation of the DLPFC can improve performance in cognitive tasks, a result that has not been mirrored through use of medications. Second, in recognition of the heterogeneity of schizophrenic patients (substantiated by the fact that the success of other treatments varies from patient to patient), our study will perform tests to identify the preferred stimulation region, DLPFC left/right. The results will help determine more specifically if there is a degree of heterogeneity in terms of the region responsible for suppressing irrelevant information . Related to this, we will be able to assess the impact of stimulation, including whether or not stimulation benefits all schizophrenic patients or, alternatively, if there are unknown variables involved which determine the relative success of this treatment amongst individuals. In addition, we will be able to explore differences or correlations between healthy subjects' verbal abilities in relation to the various tests conducted, and assess the impact of these tests on healthy subjects' cognitive inhibition and working memory. Finally, this study is critical because if the treatment method proves to be successful, we would be able to extend this study to other populations that have difficulties with executive functioning, and in addition, to examine the effect of electrical stimulation on other cognitive abilities.

Conditions
Schizophrenia
Keywords
schizophrenic patients, tDCS, Executive functions, Dorsolateral prefrontal cortex
Medical subject headings
Schizophrenia

What participants receive

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

  • transcranial direct current stimulationDevice

    Also called Active Comparator: sham tDCS

    arm Participants will receive bilateral anodal-left cathodal-right tDCS or anodal-right cathodal-left tDCS over the DLPFC.

    The following parameters will be used: stimulation intensity of 2 milliAmps for 20 minutes (6 consecutive sessions ).

  • sham tDCSDevice

    the sham tDCS group. Neuropsychological testing and symptom ratings will be conducted at baseline and 4 weeks after the end of treatment

Study groups in NCT01971073
Study groupRoleWhat they receive
bilateral Anodal-L/R Cathodal-R/L tDCSExperimentalbilateral Anodal-left and cathodal-right tDCS over DLPFC or bilateral Anodal-right and cathodal-left tDCS over DLPFC. Intervention: Device: transcranial direct current stimulation
Receives: Device: transcranial direct current stimulation
Sham tDCSSham comparatorSham tDCS
Receives: Device: sham tDCS

What is being measured

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

  1. Progression score on cognitive tasks

    Improve performance in cognitive tasks in particular, higher scores on the MATRICS Consensus Cognitive Battery in the post vs. before intervention tests.

    Measured: two years

Timeline

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

  1. First posted29 Oct 2013 (estimated)
  2. Study startJan 2015
  3. Primary completion7 Mar 2018
  4. Study completion7 Mar 2018

Why it stopped: Difficulty in financing the research

Resources

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, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971073
Sponsor's protocol ID
BARILAN-13-0116-MV-CTIL
Status last verified
Apr 2018
First submitted
12 Oct 2013
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with Schizophrenia, run by Bar-Ilan University, Israel at 1 site in Israel.

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 8 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: stopped early, as of the sponsor's last update on 27 Apr 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 Israel. 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?

The study was stopped early (reason given: Difficulty in financing the research). Results are not available in the source record.

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?

Progression score on cognitive tasks (time frame: two years). 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 27 Apr 2018.

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