TOPLINE

Electromagnetic network-targeted field (ENTF) stimulation combined with physical and occupational therapy was associated with a higher rate of freedom from disability and greater reduction in disability level than sham stimulation in patients with moderate-to-severe disability following ischemic stroke, a meta-analysis of two small clinical trials showed.

METHODOLOGY

• Researchers conducted a pooled individual patient-level data meta-analysis of two double-blind, randomized, sham-controlled trials (BQ3 and EMAGINE 1) performed at 1 site in India and 16 sites in the US, respectively.
• The 124 adults (mean age, 58.2 years; 31% women; 37% White) with subacute ischemic stroke received either active ENTF stimulation (n = 65) or sham stimulation (n = 59) combined with concurrent physical and occupational therapy exercises over approximately 9-10 weeks. The therapy started at a mean of 14.5 days after stroke.
• The primary outcome was freedom from disability, defined as a modified Rankin scale (mRS) score of 0-1, at 8-12 weeks. The mean mRS score at study entry was 3.9.
• Secondary outcomes measured at 8-12 weeks included ordinal level of disability (mRS scores combined into three groups: 0-1, 2, and 3-6), change in disability score from baseline, functional independence (mRS score of 0-2), and changes in arm motor status as measured by Fugl-Meyer assessment of the upper extremity (FMA-UE) scores and Box and Block Test (BBT) scores. Safety outcomes were also assessed.

TAKEAWAY

• Freedom from disability at 8-12 weeks was achieved by 33.8% of patients in the ENTF stimulation group compared with 11.9% of those in the sham stimulation group (risk ratio, 2.88; P = .007).
• The ordinal distribution of disability levels at 8-12 weeks favored ENTF stimulation over sham stimulation (common odds ratio, 2.88; P = .008). A greater change in the disability level at 8-12 weeks was observed with ENTF stimulation than with sham stimulation (mean change, -2.1 vs -1.7; P = .006).
• Functional independence and changes in FMA-UE and BBT scores favored ENTF stimulation over sham stimulation, but the differences were not statistically significant.
• No device- or procedure-related serious adverse events were observed, and the frequency of nonserious and serious adverse events did not differ between the two groups.

IN PRACTICE

“Treatment with ENTF compared with sham for patients with subacute ischemic stroke with moderate-severe study entry disability yielded increased achieved freedom-from-disability, greater disability improvement from study entry, and reduced final disability level. These findings, together with an attractive safety profile, support ENTF as a promising therapy for stroke recovery,” the investigators wrote.

SOURCE

The study was led by Jeffrey L. Saver, MD, Reed Neurologic Research Center, University of California, Los Angeles. It was published online on July 7 in Stroke.

LIMITATIONS

Both groups received more intensive therapy than is typical in clinical practice, potentially overestimating control group outcomes. The combined sample size remained small, women were underrepresented, and the meta-analysis was not preregistered. The two trials also differed in duration of the training while undergoing stimulation and outcome assessment timing. Most participants were inpatients, limiting the generalizability of the findings.

DISCLOSURES

The studies were funded by BrainQ Technologies Ltd, maker of the ENTF device used in both trials. Disclosure information for the study investigators is available in the original study publication.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.