NCT03037983

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2017

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

January 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 17, 2020

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

January 27, 2017

Results QC Date

June 4, 2020

Last Update Submit

August 13, 2024

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaTranscranial magnetic stimulationElectroencephalography

Outcome Measures

Primary Outcomes (4)

  • 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%.

    before treatment and after 6-week treatment

  • 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.

    before treatment and after 6-week treatment

  • 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.

    before treatment and after 6-week treatment

  • 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.

    before treatment and after 6-week treatment

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Subjects will receive actual rTMS treatment.

Device: Repetitive transcranial magnetic stimulation

Sham rTMS

SHAM COMPARATOR

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

Device: Sham

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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.

Also known as: rTMS
Active rTMS
ShamDEVICE

Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.

Sham rTMS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Jong Yoon
Organization
Palo Alto VA
jhyoon1@stanford.edu
510-220-7086

Study Officials

  • Jong H. Yoon, MD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 31, 2017

Study Start

August 1, 2017

Primary Completion

July 18, 2019

Study Completion

July 18, 2019

Last Updated

August 15, 2024

Results First Posted

August 17, 2020

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)