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Neurofeedback to Improve Working Memory in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03260257
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fiza Singh, University of California, San Diego

Brief Summary:
Schizophrenia affects 2.4 million Americans and causes significant individual and societal costs. Cognitive deficits including poor working memory arise early in the course of illness, account for poor long-term outcomes and have been difficult to treat with available treatments. The investigators are proposing to develop a novel, computer-based brain training to improve working memory in schizophrenia patients, which, if successful could have significant personal, societal, and economic impact.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Neurofeedback Not Applicable

Detailed Description:

Schizophrenia (SCZ) is a chronic debilitating mental disorder that affects 2.4 million Americans and leads to considerable individual and societal costs. In patients with SCZ, cognitive deficits (CD) occur early in the course of the illness, are associated with more severe illness, and are the best predictor of functional outcomes. Nonetheless, to date, CD have been difficult to treat using available treatments. Recent studies suggest CD in patients with SCZ may arise from abnormal synchronization of distributed neural networks. Synchronization or synchronous firing of neurons, binds cortical areas into functional networks in a task and state-dependent manner. Thus novel therapies that improve abnormal neural synchrony may improve previously refractory symptoms arising from disordered brain networks.

Neural synchrony or coherence in the gamma band (GBR, 30-45Hz) plays a central role in top-down attention, multisensory processing, perceptual binding and working memory (WM). Patients with SCZ exhibit abnormal GBR, and the magnitude of impairment is associated with the severity of cognitive disorganization. Given these results, improving GBR should improve CD, including WM in SCZ. This hypothesis has been tested and confirmed using repetitive transcranial magnetic stimulation (rTMS). Additionally, EEG-based neurofeedback (NFB) is hypothesized to improve GBR and cognitive function in patients with SCZ. NFB is a low-cost, easily administered and well-tolerated treatment. In healthy controls, Gamma-NFB improves GBR and cognitive function including WM. Thus, the investigators propose testing the feasibility and effectiveness of improving GBR using gamma-NFB in patients with SCZ using the framework of the R61/R33 mechanism.

The first trial (R61) is a proof-of-concept study designed to assess target engagement and dose response curve. Thirty SCZ patients will receive G-NFB training for 12 weeks (2 weekly sessions of 30minute duration) and be assessed for 1) evidence of training, 2) Change in GBR, 3) Change in WM and 4) Change in community functioning. The second trial (R33) aims to confirm target engagement based on training parameters obtained from R61, and to assess whether G-NFB is superior to an active-placebo neurofeedback intervention in improving GBR, WM and community functioning.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Gamma Band Response in Schizophrenia to Improve Working
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arm Intervention/treatment
Experimental: Schizophrenia patients
Thirty SCZ patients will receive neurofeedback to enhance gamma band response in an open-label, proof of concept study.
Other: Neurofeedback
Neurofeedback (NFB) will be administered to improve gamma band response. NFBs effects will be measured on gamma coherence and working memory.




Primary Outcome Measures :
  1. Change in Task related Gamma band response (gamma coherence and power) [ Time Frame: This variable will be assessed at t=0, 4 weeks, 8 weeks, 12 weeks and 4 weeks post completion of intervention ]
    Gamma-NFBs effects on gamma coherence and gamma power over time will be assessed.


Secondary Outcome Measures :
  1. Change in Working memory [ Time Frame: This variable will be assessed at t=0, 12 weeks, and 4 weeks post study completion. ]
    Gamma-NFBs effects on non-verbal working memory will be assessed over time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia/schizoaffective disorder

Exclusion Criteria:

  • Active substance use disorders in the last 30 days
  • Medication changes in the last 30 days
  • History of traumatic brain injury
  • seizure disorder
  • pregnancy

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): NCT03260257


Locations
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United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Fiza Singh, MD    858-922-4365    fsingh@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)

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Responsible Party: Fiza Singh, Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03260257     History of Changes
Other Study ID Numbers: 171020
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fiza Singh, University of California, San Diego:
Neurofeedback, Gamma band response

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