Article

This prospective, single-blinded, multicenter study assessed the
safety and efficacy of electrical epidural motor cortex stimulation (EECS) in
improving upper limb motor function of ischemic stroke patients with moderate to
moderately severe hemiparesis. METHODS: Patients >/= 4 months poststroke were
randomized 2:1 to an investigational (n = 104) or control (n = 60) group,
respectively. Investigational patients were implanted (n = 94) with an epidural
6-contact lead perpendicular to the primary motor cortex and a pulse generator.
Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to
investigational patients during rehabilitation. The primary efficacy endpoint
(PE) was defined as attaining a minimum improvement of 4.5 points in the upper
extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability
Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1,
4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring
adverse events (AEs) that occurred between enrollment and the end of
rehabilitation. RESULTS: Primary intent-to-treat analysis showed no group
differences at 4 weeks, with PE being met by 32% and 29% of investigational and
control patients, respectively
(P = .36). Repeated-measures secondary analyses
revealed no significant treatment group differences in mean UEFM or AMAT scores.
However, post hoc comparisons showed that a greater proportion of investigational
(39%) than control (15%) patients maintained or achieved PE (P = .003) at 24
weeks postrehabilitation. Investigational group mean AMAT scores also improved
significantly (P < .05) when compared to the control group at 24 weeks
postrehabilitation. Post hoc analyses also showed that 69% (n = 9/13) of the
investigational patients who elicited movement thresholds during stimulation
testing met PE at 4 weeks, and mean UEFM and AMAT scores was also significantly
higher (P < .05) in this subgroup at the 4-, 12-, and 24-week assessments when
compared to the control group. Headache (19%), pain (13%), swelling (7%), and
infection (7%) were the most commonly observed implant procedure-related AEs.
Overall, there were 11 serious AEs in 9 investigational group patients (7
procedure related, 4 anesthesia related). CONCLUSIONS: The primary analysis
pertaining to efficacy of EECS during upper limb motor rehabilitation in chronic
stroke patients was negative at 4 weeks postrehabilitation. A better treatment
response was observed in a subset of patients eliciting stimulation induced upper
limb movements during motor threshold assessments performed prior to each
rehabilitation session. Post hoc comparisons indicated treatment effect
differences at 24 weeks, with the control group showing significant decline in
the combined primary outcome measure relative to the investigational group. These
results have the potential to inform future chronic stroke rehabilitation trial
design.
CI - (c) The Author(s) 2015.

Langue : ANGLAIS