Clinical Trials Directory

Trials / Terminated

TerminatedNCT02839798

NeoSync TMS Treatment for Bipolar I Depression

Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Butler Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENEST (NeoSync EEG Synchronized TMS)The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression.

Timeline

Start date
2016-05-01
Primary completion
2018-11-19
Completion
2018-11-19
First posted
2016-07-21
Last updated
2020-04-09
Results posted
2020-04-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02839798. Inclusion in this directory is not an endorsement.