Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia

NCT02739347 | Terminated Results DMC FDA Device

• 1 other identifier: H-42322
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychosis

Keywords

tDCS; cognitive control; working memory; EEG; gamma oscillations

Outcome Measures

Primary Outcomes (2)

• Cognitive Control

  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

  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 Outcomes (2)

• Negative Symptoms

  Week 1

• Auditory Hallucinations

  Week 1

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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

Device: Active Trans-cranial direct-current stimulation

Sham Stimulation

SHAM COMPARATOR

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

Interventions

Active Trans-cranial direct-current stimulation DEVICE

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

Also known as: tDCS

Active Stimulation

Sham Trans-cranial direct current stimulation DEVICE

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

Also known as: tDCS

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (10)

• 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.

  PMID: 22581236 BACKGROUND

• 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.

  PMID: 22037126 BACKGROUND

• Cho RY, Konecky RO, Carter CS. Impairments in frontal cortical gamma synchrony and cognitive control in schizophrenia. Proc Natl Acad Sci U S A. 2006 Dec 26;103(52):19878-83. doi: 10.1073/pnas.0609440103. Epub 2006 Dec 14.

  PMID: 17170134 BACKGROUND

• 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.

  PMID: 8610818 BACKGROUND

• Lisman J, Buzsaki G. A neural coding scheme formed by the combined function of gamma and theta oscillations. Schizophr Bull. 2008 Sep;34(5):974-80. doi: 10.1093/schbul/sbn060. Epub 2008 Jun 16.

  PMID: 18559405 BACKGROUND

• 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.

  PMID: 26088110 BACKGROUND

• 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.

  PMID: 19386916 BACKGROUND

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

  PMID: 21343407 BACKGROUND

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

  PMID: 20087360 BACKGROUND

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

  PMID: 21312410 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Despite concerted and exhaustive subject recruitment efforts, the total number of patients completing the protocol was minimal. As such the sample size was inadequate for deriving any meaningful descriptive statistics or statistical comparisons.

Results Point of Contact

• Title: Raymond Cho
• Organization: Baylor College of Medicine

Raymond.Cho@bcm.edu

7137987781

Study Officials

• Raymond Cho, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 15, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 7, 2022
• Results First Posted: July 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)