Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial.

Background and purpose

Impaired upper extremity (UE) motor function is a common disability after ischemic stroke. Exposure to extremely low frequency and low intensity electromagnetic fields (ELF-EMF) in a frequency-specific manner (Electromagnetic Network Targeting Field therapy; ENTF therapy) is a non-invasive method available to a wide range of patients that may enhance neuroplasticity, potentially facilitating motor recovery. This study seeks to quantify the benefit of the ENTF therapy on UE motor function in a subacute ischemic stroke population.

Methods

In a randomized, sham-controlled, double-blind trial, ischemic stroke patients in the subacute phase with moderately to severely impaired UE function were randomly allocated to active or sham treatment with a novel, non-invasive, brain computer interface-based, extremely low frequency and low intensity ENTF therapy (1-100 Hz, < 1 G). Participants received 40 min of active ENTF or sham treatment 5 days/week for 8 weeks; ~three out of the five treatments were accompanied by 10 min of concurrent physical/occupational therapy. Primary efficacy outcome was improvement on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE) from baseline to end of treatment (8 weeks).

Results

In the per protocol set (13 ENTF and 8 sham participants), mean age was 54.7 years (±15.0), 19% were female, baseline FMA-UE score was 23.7 (±11.0), and median time from stroke onset to first stimulation was 11 days (interquartile range (IQR) 8-15). Greater improvement on the FMA-UE from baseline to week 4 was seen with ENTF compared to sham stimulation, 23.2 ± 14.1 vs. 9.6 ± 9.0,

Conclusions

ENTF stimulation in subacute ischemic stroke patients was associated with improved UE motor function and reduced overall disability, and results support its safe use in the indicated population. These results should be confirmed in larger multicenter studies.

Clinical trial registration

https://clinicaltrials.gov/ct2/show/NCT04039178, identifier: NCT04039178.

Informations de copyright

Copyright © 2022 Weisinger, Pandey, Saver, Hochberg, Bitton, Doniger, Lifshitz, Vardi, Shohami, Segal, Reznik Balter, Djemal Kay, Alter, Prasad and Bornstein.

Déclaration de conflit d'intérêts

Authors BW, AH, AB, GD, AL, OV, ES, YS, SR, YD, and AA are/were employed by the study funder, BrainQ Technologies Ltd. Authors ES and YS have ownership interest in BrainQ Technologies Ltd. Authors JS and NB serve as advisors to BrainQ Technologies Ltd. Author YS is the father of a neurologically disabled child. This study received funding from BrainQ Technologies Ltd. The funder was involved in the study design, data analysis and interpretation, and the writing of this article or the decision to submit it for publication. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.