St. Jude Medical (St. Paul, Minnesota) last week reported receiving approval of an investigational device exemption (IDE) from the FDA to begin enrollment in a clinical study of deep brain stimulation (DBS) using its Libra system to treat patients with the most severe type of depression who have not responded to other therapies.
The BROdmann Area 25 DEep brain Neuromodulation (BROADEN) study will evaluate the safety and effectiveness of DBS in patients with depression for whom currently-available treatments are not effective.
The study will build on the depression research from a team at the University of Toronto, led by neurologist Helen Mayberg, MD, now with Emory University School of Medicine (Atlanta), and neurosurgeon Andres Lozano, MD.
“There are 21 million people who suffer from depressive disorders in the U.S., and 80% can be treated with current therapies,” Rohan Hoare, VP of R&D for St. Jude’s Advanced Neuromodulation Systems (Houston) division told Medical Device Daily. “The other 20% are resistant to existing therapies.
“Our hope is to provide an avenue for these patients to get care and treatment and improve their quality of life. We’re talking about major depression where people are profoundly sad and it’s severely disabling.”
Mayberg and Lozano conducted the first study of DBS for depression in Toronto in 2003, and they published their findings in March 2005. Imaging studies led them to an area of the brain — called Brodmann Area 25 — thought to be involved in depression. This area appears to become over-active when people are profoundly sad and depressed.
“Brodmann Area 25 has been studied for a number of years and is now seen as a key junction box regulating depression,” Hoare said. “Conceptually, DBS for depression helps by inhibiting Brodmann Area 25.”
St. Jude’s Libra DBS System includes electrodes which are permanently implanted in the brain and connected to a battery-operated generator which is placed in the pectoral region of the chest.
“It’s like a pacemaker for the brain,” Hoare said.
Libra enables a healthcare professional to adjust and fine-tune the stimulation therapy. It includes a remote control device which allows patients to turn it off and on as needed.
St. Jude owns the intellectual property rights and has various patents pending for the use of neurostimulation at Brodmann Area 25.
Libra is intended to be used along with medications.
The 12-month study is a double-blind, randomized, controlled, three-site trial, in which patients who qualify will all receive active stimulation.
Hoare declined to reveal the clinical trial site locations or how many patients will be enrolled.
Participants will be randomly assigned to a therapy group or a control group, with twice as many participants receiving active treatment in the therapy group compared to the control group. After a period of six months, the control group will be activated to also receive the neurostimulation therapy.
To qualify for study enrollment, patients must be currently diagnosed with major depressive disorder; 21 to 70 years old, with onset of first episode before age 45; tried at least four treatments in their current episode; and have suffered depression for at least one year.
ANS was acquired by St. Jude in 2005(Medical Device Daily, Nov. 13, 2005).
Cyberonics (Houston) previously has been the most active in developing its Vagus Nerve Stimulation (VNS) system for forms of depression resistant to other therapies, billing its use as a therapy for treatment-resistant depression (TRD). That use of the VNS technology – originally focused on treatment of epilepsy — has been panned by critics as company creation of a disease target, since the term could simply be applied to any disease resistant to standard treatments.
While Cyberonics won FDA approval for the TRD application, the therapy has not won acceptance in the medical and psychiatric communities, with rejection of reimbursement coverage by the Centers for Medicare & Medicaid Services being a major economic barrier.
Last August, Cyberonics said it was refocusing its efforts in the epilepsy market (MDD, Aug. 31, 2007).
Other companies in the DBS space, but for other indications, include Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts) and Northstar Neurosience (Seattle).