Devices

Results of the COMMAND early feasibility study of the Synchron endovascular BCI: six participants with severe upper limb paralysis, no device-related serious adverse events at one year, and consistent decoding in four of six.

Device — Endovascular

Synchron COMMAND study results

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Synchron · Stentrode · COMMAND · endovascular · early feasibility study · FDA IDE · human

Synchron COMMAND study results

One-line verdict: The first FDA-approved trial of a permanently implanted BCI reports that the endovascular route met its safety endpoint in all six participants. Decoding was consistent in four.

Quick tags: Recording · Endovascular · Human · 12-month results

Overview

What it is: COMMAND (NCT05035823) was a prospective, multi-center, single-arm, open-label early feasibility study of the Synchron BCI, a fully implanted system delivered through a vein with a minimally invasive endovascular technique. It ran under an investigational device exemption. This follows the earlier first-in-human SWITCH study in Australia, which had four participants. See the Stentrode device entry.

Who: Six participants with chronic severe bilateral upper limb paralysis, at three US sites: Mount Sinai in New York City, UB Neurosurgery/Gates Vascular Institute, and UPMC, with Carnegie Mellon University.

What was measured: The primary endpoint was device-related serious adverse events resulting in death or permanent increased disability. Secondary endpoints were device migration and target vessel patency.

What was found (as reported): All six were successfully implanted. All six met the primary endpoint, with no such events during the one-year evaluation. Target vessel patency was preserved and there was no evidence of migration at 3 and 12 months. Four of six showed consistent decoding performance and performed various digital device control tasks throughout the year.

Caveats: Six participants, no control arm, and the abstract’s disclosures note that an author holds stock options in Synchron. Two participants did not show consistent decoding, and the abstract does not say why.

Spec Card Grid

Identity

  • Sponsor: Synchron
  • Registry: NCT05035823, IDE G210178
  • Design: single-arm, open-label, multi-center, prospective

Results

  • Implanted: 6 of 6
  • Primary safety endpoint met: 6 of 6
  • Consistent decoding: 4 of 6
  • Follow-up: one year; vessel patency and migration checked at 3 and 12 months

Evidence and limits

  • Not covered here: decoding accuracy and task speeds; these are in the full paper
  • Model: see the existing Stentrode entry

References