Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00927173
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2009-06-23
Brief Title:
Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation TMS H-Coil in the Treatment of Major Depression Disorder
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation TMS in Subjects With Major Depression Disorder MDD
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS Transcranial Magnetic Stimulation a new experimental procedure using the H-Coil in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications
Detailed Description:
This study is a multicenter randomized double blind sham controlled study to evaluate the safety and efficacy of H-coil deep transcranial magnetic stimulation dTMS as a treatment for patients with major depressive disorder who have been previously unsuccessfully treated with antidepressant medications Studies of repetitive transcranial magnetic stimulation rTMS typically using a figure-8 coil have shown that stimulating superficial brain regions can be beneficial in treating major depression Differing from traditional figure-8 coil the H-coil is designed to stimulate deep brain regions related to motivation reward and pleasure Preliminary studies have been conducted and seem to indicate that through stimulating certain brain areas with the H-coil dTMS may have an antidepressant effect The study population will consist of patients with major depressive disorder who have failed adequate medication treatment or shown significant intolerance to medications The study duration is 18 weeks with a 2 week period of weaning the patient off medication followed by 4 weeks of 5 daily treatments and 12 weeks of biweekly treatments Mood and mental state will be carefully monitored through standard psychological scales and rating during the drug taper-down and throughout treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IL-MOH-HTA-4860 | None | None | None |