Study shows deep brain stimulation encouraging for stroke patients NatureMedicine
, we applied PET as an exploratory approach to characterize treatment-related changes in cerebello-cortical physiology. In comparing pre-DBS + rehab versus post-DBS + rehab data, we observed significant group-level changes in perilesional metabolism, with subregional changes in metabolism in the majority of motor-associated cortices. In particular, changes in pre-DBS + rehab versus post-DBS + rehab PET data in ventral pre-motor cortex were found to be correlated with gains on the AMAT.
The study has limitations inherent to an early stage, Phase 1 investigation. Overall interpretation of the data presented is limited by the open-label nature of the design, the heterogeneity in baseline impairment level across the sample population, and, finally, the limited size of that same sample that are typical of a phase I neurological device trial.
In summary, this phase I study presents the first evidence of safety and feasibility of DN-DBS in individuals with chronic post-stroke hemiparesis with encouraging rehabilitative effects and associated neurophysiological gains observed across the DBS + rehab phase. This emerging intervention has shown translational potential to modulate the magnitude of neuroplastic reorganization toward recovery of function and to extend its time window to late phases of disability.
Candidates were enrolled in an open-label, non-randomized, single-arm trial with a target enrollment of 12 individuals. Participation spanned 20–24 months, with monthly assessments performed to record safety data and secondary metrics . Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone.
The study protocol and subsequent amendments were approved by the Food and Drug Administration with local approval established by the Institutional Review Board of the Cleveland Clinic. Written informed consent was obtained before study-specific testing and re-consent to protocol changes was obtained when applicable. The informed consent process was actively monitored by two neuroethicists and an independent Data Monitoring Committee .
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