Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia

June 13, 2022 updated by: Raymond Cho, Baylor College of Medicine
This study proposes to assess the effect of trans-cranial direct current stimulation (tDCS) on cognitive control, working memory, functional, clinical, and cognitive outcomes in schizophrenia patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Cognitive functions and EEG correlates will be thoroughly assessed in schizophrenia patients undergoing a tDCS treatment and compared with patients receiving a placebo stimulation. The treatment will involve 20 minutes of tDCS application to the left prefrontal and temporo-parietal cortex, twice a day for five days, a procedure shown to be effective in improving other symptoms of psychosis such as negative symptoms and hallucinations. Critically, in addition to standard neuropsychological testing, cognitive assessments will involve tasks that tap cognitive control and working memory, impairments in which comprise two of the core cognitive disturbances in schizophrenia and which have been linked to brain rhythm disturbances measurable by EEG recordings. Investigators will also assess changes in functional outcome by tDCS and investigate relationships between improvements in cognition, brain rhythms and functional outcome. All these assessments will occur just prior to tDCS application, just after completion of the tDCS series, and then again at 2 months follow-up. There will be two separate independent groups of patients who will be randomized to active versus sham treatments. The first group will have early course schizophrenia (less than 5 years of antipsychotic treatment; n=40). The second group will be chronic schizophrenia (greater than 5 years of antipsychotic treatment; n=40).

Relevance

This proposal would be the first integrated study of the effects of tDCS on cognitive symptoms, brain function and functional outcome in schizophrenia. A positive outcome would represent a marked improvement in clinical therapeutics for cognition in psychosis and provide a powerful tool for improving functional outcome in this debilitating disorder. Understanding the impact on brain rhythm disturbances could support the study of similar stimulation-based therapeutic approaches to other neuropsychiatric disorders that shows similar disturbances in cognition and brain rhythms activity, such as bipolar disorder and autism.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Early course psychosis:

  • DSM-V diagnosis of Schizophrenia, Schizoaffective disorder, or schizophreniform disorder.
  • ages 18-50 years
  • on stable doses of medication for at least one month
  • not taking benzodiazepines or mood stabilizers.
  • Mild to severe cognitive impairment in MATRICS Consensus Cognitive Battery (composite scores < 40)

Chronic psychosis:

Same as early course psychosis but >5 years of antipsychotic treatment

Exclusion Criteria:

  • Diagnostic and Statistical Manual-Version V (DSM-V) diagnosis of mental retardation
  • significant head injury
  • medical illness affecting brain function or structure
  • pregnancy or postpartum (<6 weeks after delivery or miscarriage)
  • significant neurologic disorder (e.g seizure disorder)
  • inability to provide informed consent
  • significant color blindness that affects task performance
  • Comorbidity for DSM-V substance abuse disorder within the past one month
  • Temporal relation between illness onset and head injury
  • Taking benzodiazepines or mood stabilizers (lithium allowed)
  • Positive drug screen (excluding THC at baseline)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Stimulation
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Device: Active Trans-cranial direct-current stimulation
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Other Names:
  • tDCS
Sham Comparator: Sham Stimulation
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Device: Sham Trans-cranial direct current stimulation
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Control
Time Frame: Week 1

The investigators will assess cognitive control using the Preparing to Overcome Prepotency (POP) task. The accuracy mean differences between the high and low control conditions will be used as dependent measures.

The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Week 1
Working Memory
Time Frame: Week 1

The investigators will assess working memory using a working memory task. The accuracy mean differences between the high and low control conditions will be used as dependent measures.

The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Symptoms
Time Frame: Week 1
A secondary outcome measure is the severity of negative symptoms as quantified by Scale for the Assessment of Negative Symptoms (SANS). This study is powered at 0.8 to observe a post-pre treatment improvement in negative symptoms with a moderate effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Week 1
Auditory Hallucinations
Time Frame: Week 1

A secondary outcome measure is the change over time in the severity of auditory hallucinations as assessed by the Auditory Hallucination Rating Scale (AHRS).

In a study conducted using a similar montage and current strength (Brunelin et. al 2012), a reduction in auditory hallucinations with a substantial effect size (d=1.58) was observed in 30 patients with schizophrenia. However, as their study recruited only those patients with severe hallucinations while the current study does not have such an inclusion criterion. The investigators expect a more modest effect size of d=0.60.
Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Brain & Behavior Research Foundation

Investigators

  • Principal Investigator: Raymond Cho, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-42322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be open to sharing after primary findings of study have been published.

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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