Clinical trial NCT02739347: Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
Official title: Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Psychosis
Keywords: tDCS
cognitive control
working memory
EEG
gamma oscillations
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2016-04-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cognitive Control
timeFrame: Week 1
measure: Working Memory
timeFrame: Week 1
Secondary outcomes:
measure: Negative Symptoms
timeFrame: Week 1
measure: Auditory Hallucinations
timeFrame: Week 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Raymond Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
citation: Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
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citation: Mondino M, Brunelin J, Palm U, Brunoni AR, Poulet E, Fecteau S. Transcranial Direct Current Stimulation for the Treatment of Refractory Symptoms of Schizophrenia. Current Evidence and Future Directions. Curr Pharm Des. 2015;21(23):3373-83. doi: 10.2174/1381612821666150619093648.
citation: Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
citation: Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
citation: Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.
citation: Volk DW, Lewis DA. Prefrontal cortical circuits in schizophrenia. Curr Top Behav Neurosci. 2010;4:485-508. doi: 10.1007/7854_2010_44.