TY - JOUR
T1 - Transcutaneous auricular vagus nerve stimulation to treat narcolepsy type 1 (TARGET-NT1): A two-arm, randomised, sham-controlled trial: A two-arm, randomised, sham-controlled trial
AU - Pan, Yuanhang
AU - Zhang, Yingchi
AU - Xu, Ziliang
AU - Wei, Zihan
AU - Pan, Rui
AU - Hu, Gengyao
AU - Wang, Xiaoli
AU - Yang, Lei
AU - Wu, Dianwei
AU - Zhang, Xinbo
AU - Wen, Xinyu
AU - Qu, Shuyi
AU - Li, Chenwei
AU - Zhu, Zhe
AU - Gao, Yuwen
AU - Shi, Xiaodan
AU - Zhu, Yuanqiang
AU - Wu, Kejian
AU - Wang, Duolao
AU - Liu, Yonghong
PY - 2025/5/6
Y1 - 2025/5/6
N2 - To assess exploratorily the safety and efficacy of transcutaneous auricular vagus nerve stimulation (tVNS) as an adjunctive therapy in improving symptoms in patients with narcolepsy type 1 (NT1). The TARGET-NT1 trial, a two-arm, double-blinded, sham-controlled trial was conducted from April 2022, to June 2024 at Xijing Hospital in Xi'an, China. Participants were randomised to receive tVNS treatment or sham tVNS (stVNS) treatment. Both interventions were performed for two 30-min periods per day with the same stimulation parameters but different stimulation points, for 12 weeks. The primary outcome was the change in mean sleep onset latency of maintenance of wakefulness test (MWT) from baseline to week 12. Secondary outcomes included changes in Narcolepsy Severity Scale (NSS), Epworth Sleepiness Scale (ESS), 14-item Hamilton Anxiety Rating Scale (HAMA-14), 17-item Hamilton Depression Rating Scale (HAMD-17). Among 60 randomised participants (32 men [53.3 %] and 28 [46.7 %]; mean [SD] age, 29.9 [9.9] years), 56 were included in the modified intention-to-treat (mITT) analysis. From baseline to week 12, the difference in mean change in mean sleep onset latency of MWT was 3.09 (95 % CI, 1.00, 5.88; P = 0.0041) as compared with stVNS group. Significant improvements in NSS-EDS (−2.61 [95%CI, −4.07, −1.15; P = 0.0006]), NSS-SP (−1.11 [95%CI, −1.83, −0.38; P = 0.0030]), NSS-HH (−2.71 [95%CI, −3.36, −2.05; P < 0.0001]), NSS- DNS (−0.52 [95%CI, −0.87, −0.17; P = 0.0036]), ESS (−3.03 [95%CI, −4.30, −1.75; P < 0.0001]) and HAMD-17 (−2.50 [95%CI, −4.30, −0.70; P = 0.0069]) were observed in the tVNS group as compared with stVNS group. This exploratory study supported the efficacy and safety of tVNS in patients with NT1 and provided insights into the mechanisms underlying tVNS treatment for NT1. The findings highlight tVNS as a potential non-pharmacological adjunctive therapy for patients with NT1. This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2400094550.
AB - To assess exploratorily the safety and efficacy of transcutaneous auricular vagus nerve stimulation (tVNS) as an adjunctive therapy in improving symptoms in patients with narcolepsy type 1 (NT1). The TARGET-NT1 trial, a two-arm, double-blinded, sham-controlled trial was conducted from April 2022, to June 2024 at Xijing Hospital in Xi'an, China. Participants were randomised to receive tVNS treatment or sham tVNS (stVNS) treatment. Both interventions were performed for two 30-min periods per day with the same stimulation parameters but different stimulation points, for 12 weeks. The primary outcome was the change in mean sleep onset latency of maintenance of wakefulness test (MWT) from baseline to week 12. Secondary outcomes included changes in Narcolepsy Severity Scale (NSS), Epworth Sleepiness Scale (ESS), 14-item Hamilton Anxiety Rating Scale (HAMA-14), 17-item Hamilton Depression Rating Scale (HAMD-17). Among 60 randomised participants (32 men [53.3 %] and 28 [46.7 %]; mean [SD] age, 29.9 [9.9] years), 56 were included in the modified intention-to-treat (mITT) analysis. From baseline to week 12, the difference in mean change in mean sleep onset latency of MWT was 3.09 (95 % CI, 1.00, 5.88; P = 0.0041) as compared with stVNS group. Significant improvements in NSS-EDS (−2.61 [95%CI, −4.07, −1.15; P = 0.0006]), NSS-SP (−1.11 [95%CI, −1.83, −0.38; P = 0.0030]), NSS-HH (−2.71 [95%CI, −3.36, −2.05; P < 0.0001]), NSS- DNS (−0.52 [95%CI, −0.87, −0.17; P = 0.0036]), ESS (−3.03 [95%CI, −4.30, −1.75; P < 0.0001]) and HAMD-17 (−2.50 [95%CI, −4.30, −0.70; P = 0.0069]) were observed in the tVNS group as compared with stVNS group. This exploratory study supported the efficacy and safety of tVNS in patients with NT1 and provided insights into the mechanisms underlying tVNS treatment for NT1. The findings highlight tVNS as a potential non-pharmacological adjunctive therapy for patients with NT1. This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2400094550.
KW - Excessive daytime sleepiness
KW - Narcolepsy type 1
KW - Randomized controlled trial
KW - Transcutaneous auricular vagus nerve stimulation
U2 - 10.1016/j.neurot.2025.e00604
DO - 10.1016/j.neurot.2025.e00604
M3 - Article
SN - 1933-7213
VL - 22
JO - Neurotherapeutics
JF - Neurotherapeutics
IS - 4
M1 - e00604
ER -