Dataset Information

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

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.

SUBMITTER: Edwards DJ

PROVIDER: S-EPMC10453351 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Edwards Dylan J DJ Liu Charles Y CY Dunning Kari K Fregni Felipe F Laine Jarmo J Leiby Benjamin E BE Rogers Lynn M LM Harvey Richard L RL

Stroke 20230814 9

<h4>Background</h4>To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1<sub>CL</sub>) 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.<h4>Methods</h4>The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post ...[more]

PMID: 37577801

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Project description:ObjectiveTo compare the effects of robot-assisted therapy with conventional therapy for accelerating stratified intervention in poststroke patients with upper limb dysfunction.BackgroundFor stroke survivors, recovery of upper extremity function remains a major challenge in rehabilitation. Literature has suggested that the rate of recovery may improve if treatments can be individualized to their clinical profiles. However, there still lack clinical evidence on how to create treatment tailored to individual patients. Robot-assisted Therapy (RT) provides a straightforward approach to adjustment of the assistance-resistance continuum for individual patients. In early Brunnstrom stages of recovery, patients benefit from assistance training, whereas in later stages the training is favored with resistance. Therefore, RT may enhance Conventional Therapy (CT) but the use of RT in stratified intervention has not been investigated. This study evaluated the possible benefit of adopting RT following a protocol of upper-limb training, which was stratified with the Brunnstrom stage of each individual.MethodsThis study was a single-blinded randomized controlled trial. A total of 53 patients with stroke were recruited and randomized into 2 groups (CT, n = 27, 3 dropped out and RT, n = 26, 2 dropped out). Both groups were trained once per day, 5 days per week for 4 weeks. The CT group received 30 min of conventional therapy; the RT group received 30 min of upper limb robot-assisted training. Patients were assessed at the beginning, week-2, and week-4 of the treatment. The outcome measures included the Fugl-Meyer Assessment Upper-Extremity (FMA-UE) and the Modified Barthel Index (MBI).ResultsAcross the 4-week intervention, participants in the RT group recovered 1.979 points of FMA-UE per week, compared to 1.198 points per week in the CT group (t94 = 3.333, p < 0.01); the recovery rate was 0.781 points/week higher in the RT group than in the CT group. Moreover, the recovery of FMA-UE was faster in proximal joints (t94 = 3.199, p < 0.01), and for patients in Brunnstrom Stage III (t34 = 2.526, p < 0.05). The improvements in MBI were not significantly different between RT and CT.ConclusionRobot-assisted therapy showed initial evidence for the acceleration of post-stroke recovery of motor function in the upper limb. Initial observations suggested that patients in Brunnstrom recovery stage III might benefit the most from the stratified intervention assisted by robotics.Clinical trial registrationhttps://www.chictr.org.cn/showproj.html?proj=61834, Identifier [ChiCTR2000039010]. Registered 13 March 2020.

Project description:ImportanceData from animal models show that the administration of dextroamphetamine combined with task-relevant training facilitates recovery after focal brain injury. Results of clinical trials in patients with stroke have been inconsistent.ObjectivesTo collect data important for future studies evaluating the effect of dextroamphetamine combined with physiotherapy for improving poststroke motor recovery and to test the efficacy of the approach.Design, setting, participantsThis pilot, double-blind, block-randomized clinical trial included patients with cortical or subcortical ischemic stroke and moderate or severe motor deficits from 5 rehabilitation hospitals or units. Participants were screened and enrolled from March 2001 through March 2003. The primary outcome was assessed 3 months after stroke. Study analysis was completed December 31, 2015. A total of 1665 potential participants were screened and 64 were randomized. Participants had to begin treatment 10 to 30 days after ischemic stroke. Data analysis was based on intention to treat.InterventionsParticipants were allocated to a regimen of 10 mg of dextroamphetamine (n = 32) or placebo (n = 32) combined with a 1-hour physical therapy session beginning 1 hour after drug or placebo administration every 4 days for 6 sessions in addition to standard rehabilitation.Main outcomes and measuresThe primary outcome was the difference between groups in change in Fugl-Meyer motor scores from baseline to 3 months after stroke (intention to treat with dextroamphetamine). Secondary exploratory measures included the National Institutes of Health Stroke Scale, Canadian Neurological Scale, Action Research Arm Test, modified Rankin Scale score, Functional Independence Measure, Ambulation Speed and Distance, Mini-Mental State Examination, Beck Depression Inventory, and Stroke Impact Scale.ResultsAmong the 64 patients randomized to dextroamphetamine vs placebo (55% men; median age, 66 years; age range, 27-91 years), no overall treatment-associated difference in the mean (SEM) change in Fugl-Meyer motor scores from baseline to 3 months after stroke was noted (-18.65 [2.27] points with dextroamphetamine vs -20.83 [2.94] points with placebo; P = .58). No overall treatment-associated differences in any of the study's secondary measures and no differences in subgroups based on stroke location or baseline severity were found. No adverse events were attributed to study treatments.Conclusions and relevanceTreatment with dextroamphetamine combined with physical therapy did not improve recovery of motor function compared with placebo combined with physical therapy as assessed 3 months after hemispheric ischemic stroke. The studied treatment regimen was safe.Trial registrationClinicalTrials.gov identifier: NCT01905371.

Dataset Information

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

Background

Methods

Results

Conclusions

Registration

Clinicaltrials

Publications

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

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