Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia

NCT ID: NCT02739347

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-06-30

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.

Conditions

Schizophrenia; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Stimulation

Active stimulation group will receive 20 min of 2 mA direct current stimulation.

Group Type: EXPERIMENTAL

Active Trans-cranial direct-current stimulation

Intervention Type: DEVICE

Active stimulation group will receive 20 min of 2 mA direct current stimulation.

Sham Stimulation

This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.

Group Type: SHAM_COMPARATOR

Sham Trans-cranial direct current stimulation

Intervention Type: DEVICE

This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.

Interventions

Active Trans-cranial direct-current stimulation

Active stimulation group will receive 20 min of 2 mA direct current stimulation.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

tDCS; tDCS

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Raymond Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22581236 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 17170134 (View on PubMed)

Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.

Reference Type: BACKGROUND

PMID: 8610818 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18559405 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 19386916 (View on PubMed)

Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.

Reference Type: BACKGROUND

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Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.

Reference Type: BACKGROUND

PMID: 20087360 (View on PubMed)

Volk DW, Lewis DA. Prefrontal cortical circuits in schizophrenia. Curr Top Behav Neurosci. 2010;4:485-508. doi: 10.1007/7854_2010_44.

Reference Type: BACKGROUND

PMID: 21312410 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-42322

Identifier Type: -

Identifier Source: org_study_id