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Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

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ClinicalTrials.gov Identifier: NCT03037983
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Stanford University
University of South Carolina
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in remediating cognitive deficits while also improving functionality in Veterans with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Device: Repetitive transcranial magnetic stimulation Device: Sham Not Applicable

Detailed Description:
High-frequency, repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), the dysfunctional brain region most implicated in cognitive deficits in schizophrenia, has recently been shown to improve cognition in non-Veteran samples with schizophrenia. The investigators' goal is to confirm the efficacy of this treatment modality to remediate cognitive deficits and improve functionality in Veterans with schizophrenia, as well as to gain a better understanding of the neural mechanisms responsible for cognitive deficits and their remediation. The investigators propose conducting a small-scale study to generate pilot data supporting the feasibility of conducting rTMS with Veterans and the effectiveness of rTMS in this population. In addition, the investigators will conduct neurophysiologic experiments to test whether certain neural maker of abnormal brain function improves with rTMS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Active
Subjects will receive actual rTMS treatment.
Device: Repetitive transcranial magnetic stimulation
rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.
Other Name: rTMS

Sham Comparator: Sham
Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.
Device: Sham
Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.




Primary Outcome Measures :
  1. Change in Working Memory performance accuracy [ Time Frame: before treatment and after 6-week treatment ]
    Changes in scores for Working Memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves cognition . The hypothesis will be supported if the investigators find greater WM-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05.

  2. Change in Gamma oscillation [ Time Frame: before treatment and after 6-week treatment ]
    The investigators will also be conducting electroencephalography (EEG) to measure gamma oscillation before and after rTMS. This will enable us to correlate changes in this measure with changes in cognitive performance using Pearson's bivariate correlation. A positive correlation between these variables will support the hypothesis that rTMS improves cognition by increasing gamma oscillations. The investigators will explore the possibility that pre-treatment gamma predicts rTMS responsiveness. The investigators will evaluate this possibility by conducting a median split analysis in which subjects will be binned by their baseline gamma levels. The investigators predict that those in the lower half of the distribution will show higher gamma and WM.

  3. Change in Global Functioning score [ Time Frame: before treatment and after 6-week treatment ]
    Changes in scores Global Functioning ( GF) will serve as dependent measure for testing the hypothesis that rTMS improves functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05.

  4. Brief Assessment of Cognition (BACS) [ Time Frame: before treatment and after 6-week treatment ]
    Changes in BACS score will serve as a dependent measure for testing the hypothesis that rTMS improves cognitive functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SCID confirmed diagnosis of Schizophrenia or Schizoaffective Disorder
  • Stable medication regimen (no change in dose or agents within the 2 weeks prior to study entry and throughout the duration of the study)
  • Stable social environment and housing to enable regular attendance at clinic visits
  • Ability to undergo cognitive testing, EEG scans and rTMS
  • IQ > 80 (WASI full scale score)
  • In general good medical health
  • Is in treatment with a psychiatrist and/or primary care physician within the VHA system

Exclusion Criteria:

  • Pregnant or lactating female
  • History of prior adverse reaction to TMS
  • On medications known to significantly lower seizure threshold, e.g.:

    • clozapine
    • chlorpromazine
    • clomipramine
  • History of seizures or conditions known to substantially increase risk for seizures
  • Implants or medical devices incompatible with TMS
  • Acute or unstable chronic illness that would affect participation or compliance with study procedures, e.g.:

    • unstable angina
  • Substance abuse/dependence (not including caffeine or nicotine) within one-month period prior to study entry or during study participation
  • Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:

    • active current suicidal intent or plan
    • severe psychosis
  • History of loss of consciousness greater than 15 minutes due to head injury.
  • Participation in another concurrent clinical trial
  • Patients with prior exposure to rTMS
  • Have a mass lesion, cerebral infarct or other active central nervous system disease, or history of traumatic brain injury

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): NCT03037983


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Stanford University
University of South Carolina
Investigators
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Principal Investigator: Jong H. Yoon, MD VA Palo Alto Health Care System, Palo Alto, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03037983     History of Changes
Other Study ID Numbers: D2382-P
12246865 ( Other Grant/Funding Number: Veterans Affairs - Rehabilitation R&D )
38101 ( Other Identifier: Stanford IRB )
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Schizophrenia
Transcranial magnetic stimulation
Electroencephalography

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