Clinical Trial for Patients Diagnosed with Major Depression
We are currently enrolling patients in a clinical research study to evaluate the efficacy and safety of an investigational device known as the Brainsway H-7 Coil for Major Depression. The purpose of the study is to compare the efficacy of deep TMS with the experimental H7-Coil to deep TMS with the FDA cleared, H1-Coil in subjects with Major Depressive Disorder (MDD). Eligible patients will be randomized to one of two groups. Both investigational treatment groups, H1-Coil and H7-Coil, will receive active TMS. Each investigational treatment takes about 30 minutes (of which, 20 minutes will be stimulation time) and is done on an outpatient basis.
The investigational treatment regimen consists of a total of 4 weeks of TMS, consisting of 5 daily TMS sessions per week, followed by 2 weekly TMS sessions in weeks 5 and 6. Additionally, EEG will be measured before the first and the last TMS sessions.
The Importance of Finding New Investigational Treatments
MDD is a common, recurrent, and frequent chronic disorder that is the leading contributor to functional impairment and disability (Lopez and Murray 1996). Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently from existing antidepressant interventions, including trials of medication and psychotherapy (Greden 2001). A substantial proportion of patients manifest a chronic, treatment-resistant course of illness, resulting in a need for additional treatment options (Rush, Trivedi et al. 2006, Trivedi, Rush et al. 2006). Transcranial magnetic stimulation (TMS) has been proposed as one such alternative (George and Wassermann 1994, George, Wassermann et al. 1995, George, Wassermann et al. 1997).
- Patients suffering from MDD & currently depressed
- Men and Women, 22-68 years of age
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
- Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features, Bipolar disorder, Eating disorder, Obsessive compulsive disorder
- Post-traumatic stress disorder (current or within the past year)
- Individuals with hearing loss
- ECT treatment within 3 months prior to the screening visit
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Suicide attempt in the last 3 years.
- Any self-inflicted harm in the past 3 months not in the context of suicidal ideation.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
- Implanted neurostimulators
- Ferromagnetic implanted material
- Known or suspected pregnancy
- Women who are breast-feeding
- Individuals with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- Any history of seizure EXCEPT those therapeutically induced by ECT
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Mini Mental State Exam score of less than or equal to 24
- Parkinson’s disease
- Huntington’s chorea
- Multiple sclerosis
*The criteria listed above are not exhaustive. For additional information regarding this trial or to see if you qualify, please email firstname.lastname@example.org, or call 561-333-8884.