Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

NCT ID: NCT03037983

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-07-18

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS

Subjects will receive actual rTMS treatment.

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Sham rTMS

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

rTMS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong H. Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12246865

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

38101

Identifier Type: OTHER

Identifier Source: secondary_id

D2382-P

Identifier Type: -

Identifier Source: org_study_id