Remote Versus In-Person Follow-up Programming After Subthalamic Deep Brain Stimulation for Parkinson's Disease: A Multicenter Randomized Noninferiority Trial.
Juhi Shaik, Weidong Zhang, Verena Zentsch, Carsten Buhmann, Ute Hidding, Thomas M Kinfe, Martin Regensburger, Jost-Julian Rumpf, Alfons Schnitzler, Jing Dong, Maximilian Scherer, Elisabeth Kaufmann, Johannes Levin, Alexander Crispin, Günter Höglinger, Jan H Mehrkens, Thomas Koeglsperger
Background: Remote programming of deep brain stimulation may improve access to specialized postoperative care for people with Parkinson's disease, but prospective randomized evidence remains limited.
Objective: We aimed to determine whether remote follow-up programming after standardized inpatient initiation is noninferior to conventional in-person follow-up programming for motor outcomes during the early postoperative period.
Methods: In this prospective, randomized, open-label, multicenter noninferiority trial, adults with idiopathic Parkinson's disease who recently underwent bilateral subthalamic nucleus deep brain stimulation implantation at six German centers were randomly assigned 1:1 to conventional in-person follow-up programming or remote follow-up programming through a secure telemedicine platform during the first 90 days after surgery. All participants underwent initial in-person postoperative programming before randomization. The primary outcome was the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III score at 90 days in the medication on and stimulation ON state. The prespecified noninferiority margin was 5 points.
Results: Fifty-two participants were randomly assigned. The per-protocol population included 26 participants in the conventional care group and 22 in the remote programming group. The between-group median difference of the primary endpoint was -2.5 points (95% confidence interval, -9.0 to 2.0), meeting the prespecified noninferiority criterion. Secondary clinical outcomes and patient-reported outcomes were broadly comparable between groups. Serious adverse events occurred at similar frequencies in both groups, and no deaths occurred.