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VAGUS NERVE STIMULATION PAIRED WITH UPPER LIMB REHABILITATION AFTER CHRONIC STROKE: CROSS-OVER RESULTS FROM THE VNS-REHAB PIVOTAL TRIAL.
Background and Aims
In the VNS-Rehab trial, active Vagus Nerve Stimulation (active-VNS) paired with rehabilitation led to a greater reduction in upper limb impairment compared to sham-VNS paired with rehabilitation. We report here results from participants who received sham-VNS paired with rehabilitation that crossed over to receive active-VNS paired with rehabilitation.
Forty-nine participants received 6 weeks of in-clinic sham-VNS paired with rehabilitation followed by a 90-day sham-VNS home exercise program. Participants then received 6 weeks of in-clinic active-VNS paired with rehabilitation followed by a 90-day active-VNS home exercise program. Upper limb impairment (Fugl-Meyer Upper Extremity score (FMA-UE)) was assessed at baseline, after the sham-VNS phase, after the 6-weeks of in-clinic active-VNS paired with rehabilitation and after the 90-day active-VNS home exercise program. Values are means[standard error]. Significance difference was set at p<0.05. A clinically meaningful response was defined as a >6 point change in FMA-UE score.
No related or unexpected adverse or serious adverse events were reported. FMA-UE score increased from 35.7[1.1] at baseline by +3.1[0.8] following the sham-VNS phase (p<0.0002). FMA-UE score significantly increased further by +2.8[0.5] (p<0.0001) after 6-weeks of in-clinic active-VNS and by +2.4[0.7] (p<0.002) following the 90 day active-VNS home exercise program. The overall increase from baseline to the end of the active-VNS phase was +5.9[0.9] (p<0.001). A clinically meaningful response occurred in 24% of participants following the sham-VNS phase but increased to 44% following the active-VNS phase.
On average, participants who initially received sham-VNS paired with rehabilitation achieved a further reduction in impairment following active-VNS paired with rehabilitation.