Background.
Vagus nerve stimulation (VNS) paired with rehabilitation may improve
upper-limb impairment and function after ischemic stroke.
Objective.
To report 1-year safety, feasibility, adherence, and outcome data from a
home exercise program paired with VNS using long-term follow-up data
from a randomized double-blind study of rehabilitation therapy paired
with Active VNS (n = 8) or Control VNS (n = 9).
Methods.
All
people were implanted with a VNS device and underwent 6 weeks in clinic
therapy with Control or Active VNS followed by home exercises through
day 90. Thereafter, participants and investigators were unblinded. The
Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS
group). All participants then performed an individualized home exercise
program with self-administered Active VNS. Data from this phase are
reported here. Outcome measures were Fugl-Meyer Assessment—Upper
Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box
and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor
Activity Log.
Results. There were no VNS treatment–related
serious adverse events during the long-term therapy. Two participants
discontinued prior to receiving the full crossover VNS. On average,
participants performed 200 ± 63 home therapy sessions, representing
device use on 57.4% of home exercise days available for each
participant. Pooled analysis revealed that 1 year after randomization,
the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year.
Conclusions.
VNS combined with rehabilitation is feasible, with good long-term
adherence, and may improve arm function after ischemic stroke.
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