Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial

Stroke · 8 authors, 9 centres

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TL;DR

This randomized controlled trial tested whether adding navigated 1-Hz repetitive transcranial magnetic stimulation (rTMS) to intensive motor training improved upper limb recovery after stroke. The study found that while both treatment groups improved, the rTMS did not provide any additional benefit over sham stimulation.

Full summary

1,153 CHARS

This is a parallel-arm, randomized controlled trial (E-FIT) that extended a prior trial (NICHE) to test the efficacy of navigated 1-Hz rTMS as an adjuvant to intensive motor training for upper limb recovery after stroke. A total of 60 participants with ischemic stroke, enrolled 3 to 12 months post-stroke, were randomized to receive either active rTMS (n=30) or a true sham (n=28) before each of 18 motor training sessions over 6 weeks. The primary outcome was a ≥5-point improvement on the upper extremity Fugl-Meyer score at 6 months post-treatment. The central finding was that active rTMS was not superior to sham; the response rate was 60% in the active group versus 50% in the sham group. Both groups showed significant improvements from baseline to 6 months in motor function and quality of life, attributed to the intensive training itself. The study had a relatively small sample size and was limited to patients with ischemic stroke, preventing generalization to other stroke types. The findings suggest that the tested 1-Hz rTMS protocol does not enhance the benefits of high-intensity motor rehabilitation in this chronic stroke population.

STUDY TYPE

RCT

SPECIALTY

neurology

SUMMARISED BY

AI pipeline

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ORIGINAL PAPER

PMC10453351

Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial

Stroke

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ABSTRACT

BACKGROUND: To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1 CL ) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training–related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil. METHODS: The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1 CL , preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety. RESULTS: Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61–4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%–91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%–78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D ( P <0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group ( P =0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group, P =0.72). CONCLUSIONS: Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03010462.

CITATION EXPORT

Dylan J. Edwards, Charles Y. Liu, Kari Dunning et al.. Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial. Stroke. (2023). https://doi.org/10.1161/STROKEAHA.123.043164

AUTHORS

8 · 9 CENTRES

Dylan J. Edwards, Charles Y. Liu, Kari Dunning, Felipe Fregni, Jarmo Laine, Benjamin E. Leiby, Lynn M. Rogers, Richard L. Harvey

1Moss Rehabilitation Research Institute, and Department of Rehabilitation Medicine Thomas Jefferson University, Philadelphia, PA (D.J.E.).
2Exercise Medicine Research Institute and School of Medical and Health Sciences, Edith Cowan University Australia (D.J.E.).
3Burke Neurological Institute, White Plains, NY (D.J.E.).
4USC Neurorestoration Center, Rancho Los Amigos National Rehabilitation Center, Los Angeles, CA (C.Y.L.).
5Department of Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati, OH (K.D.).
6Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA (F.F.).
7Nexstim Corporation, Helsinki, Finland (J.L.).
8Division of Biostatistics, Thomas Jefferson University, PA (B.E.L.).
9The Shirley Ryan AbilityLab, Northwestern University Feinberg School of Medicine, Chicago, IL (L.M.R., R.L.H.).