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NCT03037983

Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic Stimulation

Completed NA Results posted Last updated 15 August 2024
What this trial tests

NA trial testing Repetitive transcranial magnetic stimulation in Schizophrenia in 9 participants. Completed in 18 July 2019.

Timeline
1 August 2017
Primary endpoint
18 July 2019
18 July 2019

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposesupportive care
Enrollment9
Start date1 August 2017
Primary completion18 July 2019
Estimated completion18 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 60, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Working Memory Function Primary · 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 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

GroupValue95% CI
Active-7.28± 12.95577091
Sham-5.9± 15.55040192
Change in Neurophysiologic Function Primary · before treatment and after 6-week treatment

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.

GroupValue95% CI
Active0± .025
Sham0± .03
Change in Level of Everyday Functioning Primary · before treatment and after 6-week treatment

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.

GroupValue95% CI
Active0± 3.1
Sham-.5± 1.7
Change in General Cognitive Ability Primary · before treatment and after 6-week treatment

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.

GroupValue95% CI
Active-.104± .216
Sham.505± .374

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for one month after the initiation of the intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active
Serious: 1/5 (20%)
Deaths: 0/5
Sham
Serious: 0/4 (0%)
Deaths: 0/4

Serious adverse events (1 terms)

ReactionSystemActiveSham
Psychiatric HospitalizationPsychiatric disorders

Most-reported serious reactions: Psychiatric Hospitalization.

Data from ClinicalTrials.gov NCT03037983 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Repetitive transcranial magnetic stimulation

Trials testing the same drug.

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03037983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing