Effects of transcutaneous auricular vagus nerve stimulation combined with repetitive facilitative exercise on lower limb motor function in patients with intracerebral hemorrhage: A pilot randomized controlled trial

OBJECTIVE: To evaluate the clinical efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) combined with repetitive facilitative exercise (RFE) in improving lower limb function in patients with intracerebral hemorrhage. METHODS: The research protocol was registered on the Chinese Clinical Trial Registry website (ChiCTR2500106064). Sixty patients with intracerebral hemorrhage were randomly assigned to either the experimental group (n = 30) or the control group (n = 30). The experimental group received real taVNS combined with RFE, while the control group received sham taVNS combined with RFE. Before and after 6 weeks of treatment, functional assessments were conducted using the Fugl-Meyer Assessment-Lower Extremities (FMA-LE), the Functional Ambulation Category (FAC) scale, and a three-dimensional gait analysis system to obtain kinematic parameters of the pelvis during the walking cycle. RESULTS: Baseline demographic and clinical characteristics showed no significant differences between the two groups (all P > 0.05). After 6 weeks of intervention, both groups exhibited significant improvements in FMA-LE, FAC, stride length, peak hip extension angle, and peak hip joint moments (all P < 0.05). However, the experimental group demonstrated superior outcomes compared to the control group in FMA-LE (t = 3.233, P = 0.002), FAC (t = 2.868, P = 0.006), stride length (t = 3.077, P = 0.003), and peak hip extension angle (t = 2.682, P = 0.010). No significant difference was observed in peak hip joint moments (t = -0.212, P = 0.833) between the two groups after treatment. No adverse effects or dropouts were reported during the study. CONCLUSION: Compared to sham taVNS combined with RFE, taVNS combined with RFE can significantly enhances lower limb motor function in patients with post-stroke hemiplegia following intracerebral hemorrhage. The research protocol has been registered on the Chinese Clinical Trial Registry website (ChiCTR2500106064).