Impact of Trans-Auricular Vagus Nerve Stimulation on Arm Recovery After Stroke During Training with Khymeia Device or Traditional Rehabilitation

What this Trial Is About

Researchers are evaluating the effects of trans-auricular vagus nerve stimulation tVNS on neuromotor recovery in patients who have had a stroke within the past six months and are in the subacute phase. This randomized pilot clinical study aims to see if combining tVNS with traditional or robotic upper limb rehabilitation can enhance motor recovery. The study is sponsored by Istituti Clinici Scientifici Maugeri SpA and focuses on improving upper limb function after stroke using non-invasive nerve stimulation. Participants will be randomly assigned to one of four groups receiving either traditional rehabilitation or robotic-assisted rehabilitation with the Khymeia device. Each group will also receive either active tVNS or sham tVNS using the Parasym4 device. Active tVNS involves non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes a day, five days a week, over four weeks. Sham tVNS uses the same schedule but stimulates a non-vagal area on the left earlobe. During the study, participants will undergo assessments including the Fugl-Meyer Assessment for upper limb motor function at baseline and after four weeks of treatment. Secondary measures include tests of functional independence, cognitive abilities, mood, anxiety, and neurophysiological parameters. Researchers will monitor participants for adverse effects, expected to be minimal, and track recovery progress over the treatment period. The total study duration for each participant is four weeks of intervention with evaluations before and after treatment.

Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training