Patients with chronic poststroke hemiparesis experienced a 32% increase in strength and improved motor scores during cervical epidural stimulation in a 7-patient feasibility trial.
Patients with chronic poststroke hemiparesis experienced immediate improvements in upper-limb motor function during cervical epidural spinal cord stimulation, according to a feasibility trial. Researchers reported a 32% increase in average strength and a 5.6-point improvement in Fugl-Meyer Assessment scores from baseline with stimulation activated, with no serious adverse events observed.
Researchers conducted a prospective, single-arm, open-label feasibility trial involving 7 patients aged 31 to 64 years with chronic ischemic or hemorrhagic stroke and persistent upper-limb weakness. Participants received cervical epidural spinal cord stimulation through 2 leads implanted unilaterally in the cervical spinal cord for 29 days. The study was designed to evaluate safety, feasibility, and preliminary efficacy for improving motor function and spasticity.
Motor improvements were observed across participants regardless of baseline impairment severity. During active stimulation, researchers reported a 32% increase in strength and a 5.6-point improvement from baseline in upper-extremity Fugl-Meyer Assessment scores. Three of 7 participants with residual corticospinal connectivity to finger muscles demonstrated improved hand and finger movement during stimulation.
Researchers also reported improvements beyond the immediate stimulation period. At the end of the 4-week study, participants improved by an average of 6.6 Fugl-Meyer Assessment points compared with baseline despite completing 8.6 hours of motor activity, including 5.5 hours with stimulation activated. Spasticity decreased in all participants during the study period.
Additional analyses suggested that treatment response may vary according to underlying neurologic characteristics. The researchers reported that spared sensory function appeared to be associated with responsiveness to stimulation. They also found that selective stimulation of specific cervical spinal segments was important for achieving meaningful motor effects, particularly for hand function.
The findings should be interpreted in the context of several limitations. The study included only 7 treated patients, limiting the precision of efficacy estimates. In addition, the absence of a control group restricted interpretation of improvements observed over time. The researchers noted that the trial was designed to assess feasibility and generate preliminary evidence rather than establish definitive efficacy.
“These findings provide preliminary evidence of the safety, feasibility and efficacy of cervical SCS for chronic poststroke hemiparesis,” wrote lead study author Roberto M. de Freitas, of the University of Pittsburgh, and colleagues. The researchers added that the approach may have potential as “a fully implantable neuroprosthetic solution for assisting upper limb function in daily living.”
Disclosures: Several investigators reported patents related to the work, and several were founders and shareholders of Reach Neuro, a company developing spinal cord stimulation technologies for stroke. Additional disclosures are reported in the article.
Source: Nature Medicine
