NCT02126124

Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

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 cigarettes/day) 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DEVICE	Sham Treatment	In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the the brain.
DEVICE	Active dTMS Treatment	Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions.

Timeline

• Start date: 2014-08-20
• Primary completion: 2019-11-14
• Completion: 2019-11-14
• First posted: 2014-04-29
• Last updated: 2020-12-04

Locations

18 sites across 3 countries: United States, Canada, Israel