Dr. Henry Galperin of Jali Medical spoke with Dr. Gottfried Schlaug, Professor of Neurology and Biomedical Engineering, and Dr. Anante Shinde, Post-Doctoral Research Fellow at University of Massachusetts Medical School, Baystate about their research into stroke rehabilitation using non-invasive brain stimulation.
Dr. Gottfried Schlaug (right), Dr. Anante Shinde (left), and Dr. Henry Galperin (center) are pictured at the University of Massachusetts Medical School, Baystate with new equipment provided by Jali Medical.
The trial will use Transcranial Direct Current Stimulation, a form of electrical non-invasive brain stimulation, in combination with constraint-induced movement therapy, which is a specific type of occupational therapy where the functional limb of a stroke patient is constrained, forcing the use of the impaired limb. The trial will investigate ten sessions of intervention at three dosage levels of tDCS, and patients will be tested at baseline, after the intervention, and 3 months later. It may be that multiple sessions of the intervention are necessary to create and maintain a therapeutic effect.
The tDCS electrode montage is bi-hemispheric, with the active electrode over the affected hemisphere. This montage is based upon preliminary data and a systematic review of the existing literature. Data suggests that interventions of the affected hemisphere may be more powerful than those over the unaffected hemisphere. Dosages will be 2 milliamps of current, 4 milliamps of current, and a sham condition.
TMS will be used as a diagnostic tool along with Magnetic Resonance Imaging to examine the integrity of the corticospinal tract. These tools will be used to make predictions about who will respond best to treatment, and to look at the effects of treatment over time. The positioning of the TMS coil will use MRI-guided neuronavigation for precision, and the magnetic stimulation component will include a series of measures of corticospinal integrity and excitability.
Running a multi-center trial requires that procedures and measures be kept simple and straightforward to standardize data collection. To date only constraint-induced movement therapy has shown success as a therapeutic intervention for stroke in a multi-center trial. Oftentimes one will see a therapeutic effect of a particular modality in a single-center trial that will no longer be clinically meaningful in a large multi-center study. This is likely due to having a larger, more heterogenous population in larger studies. So understanding the variability of the study population is important.
Items marked with* are investigational devices and for research use only. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.