Results
ADVERSE EVENTS, EVENTS, ADVERSE EVENT, EVENTS
About 108 participants were randomized to either the active VNS group (n = 53) or the sham stimulation group (n = 55). Baseline characteristics are shown in Baseline Demographic and Clinical Characteristics by Randomization Group in the Intention-to-Treat Population.Abbreviations: VNS, vagus nerve stimulation; SD, standard deviation; FMA-UE, Fugl–Meyer Assessment Upper Extremity; WMFT, Wolf Motor Function Test.Participants Could Select More Than One Option for Ethnicity. FMA-UE is Out of 66 Maximum Points, With Higher Scores Meaning Better Motor Status.On the first day after completion of in-clinic therapy, the mean (±standard deviation) FMA-UE score increased by 5.0 points (4.4) in the VNS group and by 2.4 points (3.8) in the Control group (Forest plots showing mean group difference for FMA-UE change in score at day 1 (A) and day 90 (B) post completion of in-clinic therapy across different subgroups. Within each subgroup category, black square shows the mean group difference, and the size of the squares represents the degree of change. Horizontal lines denote 95% confidence. Abbreviation: FMA-UE, Fugl–Meyer Assessment Upper Extremity; VNS, vagus nerve stimulation.Forest plots showing mean group difference for WMFT change in score at day 1 (A) and day 90 (B) post completion of in-clinic therapy across different subgroups. Within each subgroup category, black square shows the mean group difference, and the size of the squares represents the degree of change. Horizontal lines denote 95% confidence. Abbreviations: WMFT, Wolf Motor Function Test; VNS, vagus nerve stimulation.Forest plots showing mean group response rate difference for FMA-UE (A) and WMFT (B) at day 90 post completion of in-clinic therapy across different subgroups. Within each subgroup category, black square shows the mean group difference, and the size of the squares represents the size of the response difference. Horizontal lines denote 95% confidence. Values to the right of the zero vertical line show a between group absolute response rate difference in favor of VNS.Abbreviations: FMA-UE, Fugl–Meyer Assessment Upper Extremity; WMFT, Wolf Motor Function Test; VNS, vagus nerve stimulation; resp, response.There were 15 reported SAEs in 12 participants. None were rated as related to study treatment or device implantation according to the investigators. There were 335 adverse events reported. The frequency of these events by subgroup is given in Table Shows the Number of Events Within Each Subgroup.Abbreviations: SAE, serious adverse event; AE, adverse event; FMA-UE, Fugl–Meyer Assessment Upper Extremity.There were a further 5 SAEs and 15 further AEs in people who did not undergo the study specific MRI scan.