NCT03260257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

6.1 years

First QC Date

August 17, 2017

Last Update Submit

May 31, 2024

Conditions

Keywords

Neurofeedback, Gamma band response

Outcome Measures

Primary Outcomes (1)

  • Change in Task related Gamma band response (gamma coherence and power)

    Gamma-NFBs effects on gamma coherence and gamma power over time will be assessed.

    This variable will be assessed at t=0, 4 weeks, 8 weeks, 12 weeks and 4 weeks post completion of intervention

Secondary Outcomes (1)

  • Change in Working memory

    This variable will be assessed at t=0, 12 weeks, and 4 weeks post study completion.

Study Arms (1)

Schizophrenia patients

EXPERIMENTAL

Thirty SCZ patients will receive neurofeedback to enhance gamma band response in an open-label, proof of concept study.

Other: Neurofeedback

Interventions

Neurofeedback (NFB) will be administered to improve gamma band response. NFBs effects will be measured on gamma coherence and working memory.

Schizophrenia patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia/schizoaffective disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • Lin Y, Shu IW, Hsu SH, Pineda JA, Granholm EL, Singh F. Novel EEG-Based Neurofeedback System Targeting Frontal Gamma Activity of Schizophrenia Patients to Improve Working Memory. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:4031-4035. doi: 10.1109/EMBC48229.2022.9870878.

MeSH Terms

Conditions

Schizophrenia

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 24, 2017

Study Start

March 1, 2018

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations