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NCT02839798 · ClinicalTrials.gov registry record · Phase 2

NeoSync TMS Treatment for Bipolar I Depression

A Phase 2 study, sponsored by Butler Hospital.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT02839798: Clinical Trial Phase 2 study, sponsored by Butler Hospital.

NCT02839798 is a Phase 2 study that was terminated before completion, run by Butler Hospital. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02839798, a Phase 2 study, was terminated before completion, sponsored by Butler Hospital.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label study in which subjects will receive treatment 5 days per week for 6 weeks.

Primary Outcome

The Montgomery-Asberg Depression Rating Scale (MADRS) will be performed as a baseline and endpoint assessments and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The MADRS score ranges from 0 to 60; a score of 0-6 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.

Interventions

  • DEVICE NEST (NeoSync EEG Synchronized TMS)

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2016-05
Est. Completion 2018-11-19
Phase Phase 2
Butler Hospital

103 total trials

Why NCT02839798 stopped before completion

NCT02839798 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which NEST (NeoSync EEG Synchronized TMS) is the first listed.

NCT02839798 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02839798 about?

NCT02839798 is a clinical study titled "NeoSync TMS Treatment for Bipolar I Depression". This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode. This is an open label study in which subjects w...

What is the current status of trial NCT02839798?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2016-05. Estimated completion is 2018-11-19.

What interventions are being tested in trial NCT02839798?

The interventions under investigation include: NEST (NeoSync EEG Synchronized TMS) (DEVICE).

Who is sponsoring clinical trial NCT02839798?

This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02839798's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02839798, the US trial registry maintained by the National Library of Medicine. NCT02839798 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.