Closed Clinical Trial
TMS Study for Treatment of Depression at Advanced Mental Health Care Inc.,
Transcranial Magnetic Stimulation (TMS) an Investigational Technique That May Have Antidepressant Effects For People With Major Depressive Disorder.
You may be eligible to take part in a research study using an investigational device if you:
- Have Major Depressive Disorder
- Are between the ages of 22-68 years old
- Have been taking medication that has not improved your symptoms
We are conducting a research study to evaluate the safety and effectiveness of an investigational device known as the Brainsway H-Coil Deep Transcranial Magnetic Stimulation (TMS) device. This study involves TMS technology. TMS is a technique for gently stimulating the brain. It uses a special magnet placed on your scalp that generates short magnetic pulses. This mechanism has a similar strength to an MRI scanner, but is more focused. Similar to an MRI scanner, the pulses pass easily through the scull. TMS produces short pulses designed to stimulate brain activities related to the control of motivation and mood.
During the procedure, the Brainsway H-Coils are placed over the skull in a specially designed helmet. A magnetic signal is generated by a short electrical current passing thought the coil and stimulates the brain. The changes in the magnetic fields in the brain cause electrical current, which may affect brain activity and function. The The H-Coil device technology is based on a applying deep brain TMS by means of repetitive pulses at a determined frequency. This may affect the brain activity as it relates to depression. Your participation in the study will last for several weeks.
During the first two weeks, you will gradually stop taking any medications used to treat your depression. You will then receive the procedure 5 days a week for 4 weeks, followed by procedures twice a week for the next 12 weeks. Each study procedure will take about 20 minutes to complete. It is possible that you may be assigned to a sham device during the study – which means that you will have the procedure, but the device is inactive and will have no effect on your depression. Your mood and mental state will be carefully monitored during your participation in these studies.
There will be no cost to you for taking part in this research. Study-related visits, procedures and tests will be provided to you at no cost.
If you are interested in taking part in this study or others, or if you have any questions, please call use at: (561) 333-8884 between 9am – 5pm
Principal Investigator: Aron Tendler, M.D.
11903 Southern blvd.
Royal Palm Beach, FL 33411
790 Juno Ocean Walk
Juno Beach, FL 33408