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Published on: December 29, 2023
ENTF Neuromodulation Yields Reduced Disability After Stroke: An Individual Participant-Level Data Meta-Analysis
Jeffrey L Saver1, Joel Stein2,3, Steven C Cramer1,4
1Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles (J.L.S., S.C.C.).
Electromagnetic network-targeted field (ENTF) brain stimulation therapy significantly improved recovery and reduced disability in subacute ischemic stroke patients. This promising treatment showed higher rates of freedom from disability and greater functional improvement compared to sham interventions.
Area of Science:
- Neurology
- Rehabilitation Medicine
- Biomedical Engineering
Background:
- Subacute ischemic stroke leads to significant disability.
- Electromagnetic network-targeted field (ENTF) brain stimulation is a novel therapy for post-stroke recovery.
- Previous pilot trials indicated safety and potential efficacy of ENTF.
Purpose of the Study:
- To perform a pooled analysis of two randomized controlled trials.
- To precisely characterize the effect of ENTF on stroke recovery and disability reduction.
- To increase statistical power for evaluating ENTF's therapeutic potential.
Main Methods:
- Pooled individual patient data from two double-blind, randomized, sham-controlled trials (BQ3 and EMAGINE 1).
- Included patients with ischemic stroke between 4 to 21 days post-event and Fugl-Meyer upper extremity scores of 10-45.
- Primary outcome: freedom-from-disability (modified Rankin Scale score 0-1) at 8-12 weeks; secondary outcomes included disability levels and upper extremity motor function.
Main Results:
- 124 patients included (65 active ENTF, 59 sham); mean age 58.2 years.
- Freedom-from-disability at 8-12 weeks was significantly higher in the active ENTF group (33.8%) versus sham (11.9%; P=0.005).
- Ordinal shift in disability strata and disability improvement favored ENTF; no serious adverse events reported.
Conclusions:
- Pooled data demonstrate ENTF significantly increases freedom-from-disability in subacute ischemic stroke patients.
- ENTF therapy leads to greater disability improvement and reduced final disability levels compared to sham.
- ENTF shows a favorable safety profile, supporting its role as a promising stroke recovery therapy.
