Trial Information

Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that time frame.

Patient Inclusion Criteria:

Aged 22 to 65 years (inclusive)
Current diagnosis of Major Depressive Disorder
Duration of current episode is less than 2 years
Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits

Patient Exclusion Criteria:

History of bipolar disorder, obsessive compulsive disorder, or psychotic disorder
Current or recent eating disorder or PTSD
Currently being treated for ADHD
Any condition likely to be associated with increased intracranial pressure
Some neurological disorders, like:

Space occupying brain lesion
History of stroke
Transient ischemic attack within two years
Cerebral aneurysm
Dementia
Parkinson's disease
Huntington's disease
Multiple sclerosis

Increased risk of seizure for any reason
Current hospitalization due to severity of depression symptoms
History of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding

University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine
2250 Chapel Avenue West
Suite 100
Cherry Hill, NJ 08002
Phone: 856-482-9000 ext. 504
Email: cmdnt@umdnj.edu

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Research Center Information: University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine

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