Ignite Creation Date:
2024-05-06 @ 2:46 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02126124
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2014-04-27
Brief Title:
Evaluation of Deep Transcranial Magnetic Stimulation DTMS With the H-ADD Coil as an Aid to Smoking Cessation
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
A Prospective Double Blind Randomized Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation DTMS With the H-ADD Coil Intended as an Aid to Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2019-11
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 safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic heavy 10 cigarettesday cigarette smokers
Detailed Description:
This is a multi center randomized double blind study to evaluate the safety and effectiveness of the device as an aid to smoking cessation Treatment will be administered over a 6 week period and follow-up assessments will be conducted at 4 months The clinical study design includes multiple measurements of safety and effectiveness parameters The design is meant to demonstrate that the device shows superiority compared to sham treatment over six treatment weeks at the 4 months follow up
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