Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Schizophrenia Clinical Trial

Official title:

Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037983
• Other study ID #: D2382-P
• Secondary ID: 1224686538101
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 18, 2019

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Stanford University, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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