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Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02739347
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Raymond Cho, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Device: Active Trans-cranial direct-current stimulation Device: Sham Trans-cranial direct current stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
Study Start Date : May 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: tDCS




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Early course psychosis:

  • DSM-V diagnosis of Schizophrenia, Schizoaffective disorder, or schizophreniform disorder.
  • ages 18-50 years
  • within first five years of anti-psychotic treatment
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739347


Contacts
Contact: Cristin Rodriguez, BS 713-798-7786 Cristin.Rodriguez@bcm.edu
Contact: Megan Rafferty, BS 713-798-7613 Megan.Rafferty@bcm.edu

Locations
United States, Texas
UT Health Science Center at Houston Recruiting
Houston, Texas, United States, 77054
Contact: Cristin Rodriguez    713-486-2839    Cristin.Rodriguez@uth.tmc.edu   
Sponsors and Collaborators
Baylor College of Medicine
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Raymond Cho, MD Baylor College of Medicine

Publications:

Responsible Party: Raymond Cho, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02739347     History of Changes
Other Study ID Numbers: HSC-MS-15-0764
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be open to sharing after primary findings of study have been published.

Keywords provided by Raymond Cho, Baylor College of Medicine:
tDCS
cognitive control
working memory
EEG
gamma oscillations

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders