The associate staff member in the department of neurology at Cleveland Clinic discussed the major take-home points and post-hoc findings from a positive study of deep brain stimulation in poststroke patients. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"The remarkable part was how, even with modest expectations due to the limited sample size, we were genuinely excited by the outcomes of the initial patient and those that followed. Witnessing our ability to achieve and sometimes exceed the targeted benefits was undoubtedly a high point."
Despite improvements in outcomes in the early hours after stroke, technological leaps for the post-acute phase have been slower. Even with contemporary techniques, up to 50% of stroke survivors experience chronic disability after stroke and often require the assistance of others to complete activities of daily living. Several in the field have explored a wide range of neurostimulation-based treatment approaches aimed at modulating neuroplasticity and improving outcomes.
Recently published in Nature, a phase 1 study led by researchers at Cleveland Clinic assessed a new, invasive surgical approach for extending the degree and temporal window of neuroplasticity after ischemic and traumatic insults to the brain. Led by Andre Machado, MD, PhD, and Kenneth Baker, PhD, the study included 12 post-stroke patients with persistent moderate-to-severe upper extremity impairment who were treated with deep brain stimulation of the cerebellar dentate nucleus. This specific approach aimed to modulate neural activity and ipsilesional cortical excitability through activation of the robust, endogenous dentatothalamocortical pathway.
At the conclusion of the open-label trial, participants demonstrated a 7-point improvement on the Upper-Extremity Fugl-Meyer Assessment. In a subgroup analysis of those with partial preservation of distal motor function at baseline, findings showed that this group exceeded minimally clinically important difference regardless of time since stroke, with a median improvement of 15 Upper-Extremity Fugl-Meyer points.
Following the publication, NeurologyLive® sat down with Baker, an associate staff member in the department of neurology at Cleveland Clinic, to learn more about the results. Baker spoke on the greatest take-home points of the early-stage trial, including promising safety findings and the significance of the post-hoc data observed. In addition, he spoke about how the post-hoc findings raise questions about the population’s heterogeneity and how they might shape future clinical trials.