A new multi-center trial clinical trial now under way has the potential to "open up a whole new world of treatment" for patients recovering from stroke, says Gary Abrams, MD, chief of the rehabilitation service at the San Francisco VA Medical Center and associate professor of clinical neurology at UCSF. Abrams is site co-principal investigator at UCSF and SFVAMC.
The trial is designed to test the safety and effectiveness of an experimental device that applies electrical stimulation directly to a patient's brain while the patient receives post-stroke physical therapy. The device was developed by Northstar Neuroscience, which is sponsoring the trial. Patients in the study are randomized to receive either intensive physical therapy alone or therapy combined with electrical brain stimulation.
"The basic notion is that low-level electrical stimulation of the brain, when combined with intensive rehabilitation therapy, will enhance long-term recovery of physical function compared with physical therapy alone," explains Abrams, who is also director of the neurorehabilitation program at UCSF. "This effect has been observed in experimental animals. There seems to be a change in the growth pattern of neurons in the area receiving stimulation, but the exact mechanism is not entirely clear."
The study focuses on stroke survivors who have hand or arm weakness, which Abrams notes has a profound effect on the ability to carry out activities of daily living. "Stroke patients usually recover walking ability to a much greater extent than they recover arm function. If, after therapy, a person can now put a key in the door or feed themselves better, this can make a big difference in quality of life."
The study "combines the talents of experts who don't always necessarily work together in clinical investigations," says Dr. Abrams. As a neurologist, Abrams assesses patients for deficits and medical issues. Patients then report to the magnetic resonance imaging facility at SFVAMC, where assistant research scientist Linda Chao, PhD, uses MRI to identify the spot in the brain that "lights up" when the patient attempts a simple hand exercise. For patients who have been randomized to electrical stimulation, co-principal investigator Nicholas Barbaro, MD, a professor of neurosurgery at UCSF, surgically implants a cortical stimulation electrode in the appropriate spot atop the dura, the membrane that covers the surface of the brain. The power pack for the stimulator is over the chest cavity, with the wires running beneath the skin, so that the entire unit is enclosed. The device is controlled wirelessly through a handheld computer operated by the clinician.
Also on the investigative team are Nancy Byl, PhD, PT, Chair of Physical Therapy and Rehabilitation Science at UCSF; Wade Smith, MD, PhD, head of the UCSF Neurovascular Service; Sharon Gorman, MS, PT, Joy Caguimbaga, DPT, PT, Trese Biagini, MS, and Mary Farrant, RN, MS.
Patients in both study groups receive six weeks of intensive rehabilitation therapy, with the stimulation group receiving electrical brain stimulation during therapy sessions. Patients are followed up for 24 weeks after treatment, "which is actually an excellent indicator of long-term results," according to Abrams. "In preliminary studies, it looked as if early improvement with electrical stimulation was maintained over time, while in patients who just received physical therapy, improvement was not sustained."
Abrams describes the project as "a new way to improve recovery after stroke. There's little available in the field for stroke patients with hand or arm weakness. If it's successful, the same principal could potentially be applied to the treatment of stroke patients who have difficulty speaking or walking."
The study is currently recruiting patients. To be eligible, a patient must be at least four months post-stroke, with hand or arm weakness but some arm function. For more information, please contact Trese Biagini at (415) 502-2094.