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Clinical Summary

Implantable neurostimulator curbs stroke damage in some patients

Takeaway

  • Use of an injectable implant to stimulate the sphenopalatine ganglion (SPG) did not improve 3-month functional outcome among patients with acute ischemic stroke overall, but it did among the subset having confirmed cortical involvement.

Why this matters

  • Need for better stroke therapies, and ineligibility of some patients for thrombolytic therapy.

Key results

  • In modified intention-to-treat population, no significant difference between active and sham stimulation in proportion of patients having 3-month disability level better than expected (49% vs 45%; OR, 1.14; P=.31).
  • But in population with confirmed cortical involvement, proportion greater with active stimulation (50% vs 40%; OR, 1.48, P=.0258).
  • Inverse U-shaped dose-response relationship between attained stimulation intensity and outcome seen in population with confirmed cortical involvement (P=.0034).
  • Active and sham stimulation groups were similar on serious adverse events (30.0% vs 28.1%), mortality (14.2% vs 12.3%).

Study design

  • International randomized controlled trial: 1078 patients aged 40-85 years with anterior-circulation acute ischemic stroke not undergoing reperfusion therapy (ImpACT-24B trial).
  • Randomization: double-blind active vs sham SPG stimulation 8-24 hours after stroke onset.
  • Main outcome: proportion with 3-month level of disability improved above expected (modified Rankin Scale score).
  • Funding: BrainsGate Ltd.

Limitations

  • Absence of vessel, penumbral imaging.
  • Stimulation assessed as standalone therapy.

References


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