Multi-site study will use non-invasive brain stimulation to try to get stroke-disabled hands moving
“You see? You see that twitch?”
Wayne Feng has just shocked his colleague, Pratik Chhatbar — literally. They’re showing how stimulating the brain with magnetic electricity in exactly the right place can cause it to send a message to the hand, making it twitch. It demonstrates a good connection between the brain and the hand.
The Medical University of South Carolina researchers will use that test to select stroke patients for a national $8 million non-invasive brain stimulation trial called TRANSPORT2. “For brain stimulation to work, you likely have to have something left in the brain that can be zapped,” Feng says.
The trial will use transcranial direct current stimulation, or tDCS, to try to get part of stroke patients’ brains to function again. It’s funded by the National Institutes of Health.
TRANSPORT2 will be the latest test in a years-long effort to use brain stimulation to help stroke victims regain control over arms and legs that quit working after a stroke. The four-year Phase II trial will focus on reducing motor impairment, improving hand function and enhancing quality of life. Feng, a stroke neurologist, is lead principal investigator. Gottfried Schlaug from Beth Israel Deaconess Medical Center is co-principal investigator.
The trial is part of the NIH’s StrokeNet, a clinical trial network created 5 years ago to streamline the process for getting promising stroke-related research through clinical trials. MUSC is a regional coordinating center as well as a national data management center for the StrokeNet.
“We are the first approved project in stroke recovery, so we’re really excited about this,” Feng says. “The process is rigorous and the competition for funding is fierce.”
The four-year TRANSPORT2 trial will involve nine clinical centers, including MUSC. As the contact principal investigator, Feng will oversee the project and handle communication about the study between the researchers and the NIH. He expects to start enrolling trial participants in the fall.
The study will compare the effects of three things:
Feng led a previous study that showed a higher-than-conventional dose of tDCS is safe and well tolerated by stroke survivors. “The new trial is a logical next step following up on a previous study. It will help us select the most efficacious dosing group that can proceed to a Phase III confirmatory clinical trial that will finally determine the efficacy of this device.”
TDCS involves using electrodes placed on the scalp to deliver a weak electrical current to the brain, stimulating it. Feng says it’s not invasive and causes no pain. “The subjects just felt itching and tingling based on the Phase I study, and it went away when the current was turned off.”
The researchers will collect brain images and transcranial magnetic stimulation data about the connection between the brain and the hand to predict which stroke patients in the future are more likely to recover or benefit this treatment. “No therapy is going to be a panacea for all stroke patients,” Feng says.
All trial participants will get 10 days of intensive physical therapy over a two-week period regardless of what dose — if any — of tDCS they’re getting.
Feng, who says he decided to specialize in stroke research and treatment after his grandmother suffered several strokes, calls the TRANSPORT2 study exciting. “This could potentially be huge. In the next a few years, we may develop a new treatment for millions of stroke survivors with disabling motor deficits.”