Efficacy and Safety of High-Dose TBS on Poststroke Upper Extremity Motor Impairment: A Randomized Controlled Trial

Author:

Tang Zhiqing12ORCID,Huang Jianting345,Zhou Ying3ORCID,Ren Jianxun3ORCID,Duan Xinyu3,Fu Xiaoxuan3,Pan Ruiqi6ORCID,Wang Rongrong12,Zhang Ping3,Ding Mengying6,Sun Jian6,Zhang Xiaonian12,Chi Qianqian12,Zhang Yue12,Zhang Xin12,Yu Weiyong17,Xu Liu8,Zhang Hao12910ORCID,Liu Hesheng311ORCID

Affiliation:

1. School of Rehabilitation, Capital Medical University, Beijing, China (Z.T., R.W., Xiaonian Zhang, Q.C., Y. Zhang, Xin Zhang, W.Y., H.Z.).

2. Department of Neurorehabilitation (Z.T., R.W., Xiaonian Zhang, Q.C., Y. Zhang, Xin Zhang, H.Z.), Beijing Bo’ai Hospital, China Rehabilitation Research Center, Beijing.

3. Changping Laboratory, Beijing, China (J.H., Y. Zhou, J.R., X.D., X.F., P.Z., H.L.).

4. Academy for Advanced Interdisciplinary Studies (J.H.), Peking University, Beijing, China.

5. Chinese Institute for Brain Research, Beijing, China (J.H.).

6. Neural Galaxy, Inc, Beijing, China (R.P., M.D., J.S.).

7. Department of Radiology (W.Y.), Beijing Bo’ai Hospital, China Rehabilitation Research Center, Beijing.

8. West China Medical School, Sichuan University, Chengdu (L.X.).

9. University of Health and Rehabilitation Sciences, Qingdao, China (H.Z.).

10. Cheeloo College of Medicine, Shandong University, Jinan, China (H.Z.).

11. Biomedical Pioneering Innovation Center (H.L.), Peking University, Beijing, China.

Abstract

BACKGROUND: Upper extremity (UE) motor function impairment is a major poststroke complication whose recovery remains one of the most challenging tasks in neurological rehabilitation. This study examined the efficacy and safety of the personalized neuroimaging–guided high-dose theta-burst stimulation (TBS) for poststroke UE motor function recovery. METHODS: Patients after stroke with UE motor impairment from a China rehabilitation center were randomly assigned to receive high-dose intermittent TBS (iTBS) to ipsilesional UE sensorimotor network, continuous TBS (cTBS) to contralesional UE sensorimotor network, or sham stimulation, along with conventional therapy for 3 weeks. The primary outcome was the score changes on the Fugl-Meyer assessment-UE from baseline to 1 and 3 weeks. The secondary outcomes included the response rate on Fugl-Meyer assessment-UE scores posttreatment (≥9-point improvement) and score changes in multidimensional scales measuring UE, lower extremity, and activities and participation. RESULTS: From June 2021 to June 2022, 45 participants were randomized and 43 were analyzed. The iTBS and continuous TBS groups showed significantly greater improvement in Fugl-Meyer assessment-UE (mean improvement, iTBS: 10.73 points; continuous TBS: 10.79 points) than the sham group (2.43 points) and exhibited significantly greater response rates on Fugl-Meyer assessment-UE (iTBS, 60.0%; continuous TBS, 64.3%) than the sham group (0.0%). The active groups consistently exhibited superior improvement on the other 2 UE assessments at week 3. However, only the iTBS group showed greater efficacy on 1 lower extremity assessment than the sham group at week 3. Both active groups showed significant improvements in activities and participation assessments. CONCLUSIONS: The study provides evidence for the efficacy and safety of high-dose TBS in facilitating poststroke UE rehabilitation. REGISTRATION: URL: www.chictr.org.cn ; Unique identifier: ChiCTR2100047340.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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