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Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sham
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia, Transcranial magnetic stimulation, Electroencephalography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SCID (Structured Clinical Interview for DSM Disorders) 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 (intelligence quotient) > 80 (WASI full scale score)
  • In general good medical health
  • Is in treatment with a psychiatrist and/or primary care physician within the VHA (Veteran's Health Administration) 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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

Subjects will receive actual rTMS treatment.

Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.

Outcomes

Primary Outcome Measures

Change in Working Memory Function
Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory 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. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%.
Change in Neurophysiologic Function
Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations.
Change in Level of Everyday Functioning
Changes in Global Functioning Scale scores (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. Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning.
Change in General Cognitive Ability
Changes in Brief Assessment of Cognition (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. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2017
Last Updated
August 14, 2020
Sponsor
VA Office of Research and Development
Collaborators
Stanford University, University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03037983
Brief Title
Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Official Title
Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Stanford University, University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Transcranial magnetic stimulation, Electroencephalography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
Subjects will receive actual rTMS treatment.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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 Measure Information:
Title
Change in Working Memory Function
Description
Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory 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. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%.
Time Frame
before treatment and after 6-week treatment
Title
Change in Neurophysiologic Function
Description
Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations.
Time Frame
before treatment and after 6-week treatment
Title
Change in Level of Everyday Functioning
Description
Changes in Global Functioning Scale scores (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. Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning.
Time Frame
before treatment and after 6-week treatment
Title
Change in General Cognitive Ability
Description
Changes in Brief Assessment of Cognition (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. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3.
Time Frame
before treatment and after 6-week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SCID (Structured Clinical Interview for DSM Disorders) 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 (intelligence quotient) > 80 (WASI full scale score) In general good medical health Is in treatment with a psychiatrist and/or primary care physician within the VHA (Veteran's Health Administration) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong H. Yoon, MD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

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