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NCT03288779 · ClinicalTrials.gov registry record · NA

Theta Burst Stimulation for Schizophrenia

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
6
Enrollment target

NCT03288779: Completed NA study, sponsored by Duke University.

NCT03288779 is a NA study that has completed, run by Duke University. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03288779, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

Purpose and objective Schizophrenia is a chronic debilitating illness with cognitive deficits that cause serious impairment in psychosocial recovery and with few treatments to remediate these deficits. One area that holds great promise for the development of novel, effective therapies is noninvasive brain stimulation. The investigators have used one form of brain stimulation, transcranial magnetic stimulation (TMS), for some time to modulate and enhance cognitive function in the brain, especially working memory (WM) function, which has a central role in most executive processing that occurs in the brain. Theta burst stimulation (TBS) is a paradigm of TMS which has been shown to effectively modulate WM. Moreover, TBS can modulate gamma neural oscillations in the brain and neural activity, both of which have been implicated in the physiology of WM and pathophysiology of the disease process in schizophrenia, making these measures highly valuable for assessing physiological effects of TBS on cognition, quality of life and cortical inhibition. The purpose of this study is to evaluate the effect of TBS on WM in patients with schizophrenia, to develop evidence for potential brain stimulation techniques to treat cognitive deficits in schizophrenia. Study activities and population group: Study subjects will be inpatient schizophrenic individuals with minimal positive symptoms and predominant cognitive deficits at Duke University Hospital. In an initial session they will be screened and taught a WM task. Following this, one TBS session will follow in which TBS will target dorsolateral prefrontal cortex. They will perform the WM task before, with and after the TBS, with an expected pre-post enhancement of WM performance. Implications - There is a great need for treatments for cognitive deficits in schizophrenia. The results of this study will serve to generate pilot data for a much larger grant to develop a TBS therapy for remediating such cognitive deficits.

Primary Outcome

Performance on tasks included in the Brief Assessment of Cognition in Schizophrenia (BACS) battery, task performed and results recorded on IPAD. The mean change from baseline in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the

Interventions

  • DEVICE Theta Burst Stimulation

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2017-10-24
Est. Completion 2018-06-30
Phase NA
Duke University

1,725 total trials

What the finished NCT03288779 record still lists

NCT03288779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Theta Burst Stimulation is the first listed.

NCT03288779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03288779 about?

NCT03288779 is a clinical study titled "Theta Burst Stimulation for Schizophrenia". Purpose and objective Schizophrenia is a chronic debilitating illness with cognitive deficits that cause serious impairment in psychosocial recovery and with few treatments to remediate these deficits. One area that holds great promise for the development of novel, effective therapies is noninvasive...

What is the current status of trial NCT03288779?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2017-10-24. Estimated completion is 2018-06-30.

What interventions are being tested in trial NCT03288779?

The interventions under investigation include: Theta Burst Stimulation (DEVICE).

Who is sponsoring clinical trial NCT03288779?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03288779's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03288779, the US trial registry maintained by the National Library of Medicine. NCT03288779 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.