Neurostar® transcranial magnetic stimulation (TMS) Therapy system, developed by Neuronetics, Inc., has received the U.S. Food and Drug Administration (FDA) clearance for the treatment of depression. The device is the first and only non-invasive and non-systemic treatment approved for major depressive disorder in adult patients, who have failed to benefit from previous antidepressant medications.
The TMS Therapy device delivers highly focused MRI-strength magnetic pulses to stimulate the neurons in the area of the brain linked to depression. The 40-minute psychiatrist-prescribed outpatient procedure does not require sedation or anesthesia, and is usually administered on a daily basis for 4 to 6 weeks.
The different components of the neuromodulation device include
- Treatment chair, designed for optimal patient comfort and positioning
- Treatment coil that converts electrical current to MRI-strength magnetic fields
- Practice data management system (PDMS) to streamline treatment data
- SenStar® Treatment Link, a patient interface device attached to the treatment coil to ensure its correct position, helps achieve magnetic field confirmation for providing patients with desired treatment
- Mobile console, which dispatches electric current to treatment coil
- Touchscreen display that serves to operate the system.
To obtain FDA approval for NeuroStar TMS, a randomized controlled trial led by Phil Janicak, Professor of Psychiatry at Rush University, Chicago was conducted on 164 patients with unipolar, non-psychotic major depressive disorder. Safety, efficacy, and tolerability of TMS system as a monotherapy was determined in these patients, who had earlier failed to show any significant improvement from prior antidepressant medications. All subjects had an extensive treatment history with a mean of 4 total antidepressant treatment attempts. The safety results demonstrated that there were no systemic side effects such as weight gain, sexual dysfunction, nausea, sedation, and dry mouth. Also, there was absence of seizures, device-drug interactions and lack of adverse effects related to concentration or memory in the TMS treated patients.
The efficacy results of the study showed
- Statistically significant response rate (percentage of patients with a >50% improvement in symptoms) and remission rate(percentage of patients attaining almost complete resolution of symptoms)
- Significant score change at 4 weeks compared to placebo, according to the Montgomery-Asberg Depression Rating Scale (MADRS) and Hamilton Depression Rating Scale (HAMD)
- Significant improvements in core depression and anxiety symptoms, psychomotor retardation, and somatization based on the HAMD scores.
Contraindications for Neurostar TMS Therapy include patients with implanted metallic devices or non-removable metallic objects located in and around the head. Additionally, the efficacy of the device has not been studied on patients who have not received any previous antidepressant treatment.
Major depressive disorder, a debilitating illness, may severely disrupt life by affecting sleep, appetite, work, and relationships. Although there is no single known cause of depression, it commonly results due to a combination of genetic, environmental, biochemical, and psychological factors. The condition can be treated by various methods such as antidepressant medications (selective serotonin reuptake inhibitors, tricyclic antidepressants), electroconvulsive therapy and psychotherapy. However, most of the antidepressants are associated with several adverse effects such as suicidal behavior, worsening of depression, sleeplessness, and agitation.
According to the National Alliance on Mental Illness statistics, major depression affects around 15 million adults in US annually, and is estimated to become the second largest health burden globally, by 2020 4. Current treatment modalities for the illness are either ineffective or associated with several adverse effects. Now, with the recent approval from FDA, NeuroStar TMS Therapy system has the potential to serve as a safe and effective non-invasive treatment option for depression, thereby lessening the social and economic impact of the disease.
About Neuronetics, Inc.: Headquartered in Malvern, Pennsylvania, Neuronetics is a privately held company that focuses on the development of non-invasive therapies for neurological and psychiatric disorders using MRI-strength magnetic field pulses.
1. FDA Clears Neurostar® TMS Therapy For The Treatment Of Depression. Press Release. Neuronetics, Inc. Last accessed October 14, 2008.
2. Neurostar TMS Therapy System. Neuronetics, Inc. Last accessed October 14, 2008.