Objective: Conduct a prospective feasibility study to determine the effects of ECAP-controlled closed-loop spinal cord stimulation (SCS) on motor symptoms in Parkinson’s disease (PD) patients.

Background: Prior research has shown promising but inconsistent clinical outcomes of SCS in treatment of PD symptoms. Recently, a novel, fully-implantable SCS technology utilizing evoked compound action potentials (ECAPs) to control stimulation dose, and therefore sensory afferent activation, has been developed. The consistent activation of dorsal spinal cord modulation by utilizing closed-loop SCS may provide enhanced, positive effects on PD symptoms.

Method: A prospective, single-arm, open-label, multi-center clinical feasibility study is being conducted. Subjects with idiopathic Parkinson’s disease presenting with tremor and/or freezing of gait (FOG) will be screened for eligibility. Leads will be implanted in the cervical and/or thoracic epidural space based upon presentation of symptoms. Subjects will be followed for 12 months.

The clinical outcomes that will be collected include the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Berg Balance Scale (BBS), Timed Up and Go (TUG) test, New Freezing of Gait Questionnaire (NFOG-Q), Parkinson’s Disease Quality of Life questionnaire (PDQ-39), PROMIS Short Forms Anxiety 4a and Depression 4a, and a pain assessment. A biometric recording device will be used during the neurological assessments to collect objective data on tremors, balance, and gait. In addition, real-time neurophysiologic recordings will be continuously collected while the stimulator is on during the procedure and outside the clinic.

Results: Neurophysiologic and clinical outcome data will be analyzed to evaluate the effect of closed-loop SCS on PD symptoms.  Moreover, relationships between the epidural electrophysiology, clinical outcomes and objective measures will be analyzed. Late-breaking results from this study will be presented.

Conclusion: This represents the first study to systematically examine the effects of ECAP-controlled closed-loop SCS on PD symptoms. These preliminary results will advance our understanding of basic spinal cord neurophysiology and the ability of closed-loop stimulation to positively impact motor function and quality of life in PD patients.

« Back to 2024 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/a-prospective-multicenter-single-arm-feasibility-study-examining-ecap-controlled-closed-loop-spinal-cord-stimulation-for-parkinsons-disease-ecap-pd-technical-and-design-considerations/