Cerebral Theta-Burst Stimulation Combined with Physiotherapy in Patients with Incomplete Spinal Cord Injury: A Pilot Randomized Controlled Trial.

"The authors have no conflicts of interest to declare."

"This study was supported by the Key Research and Development Program of Anhui Province, China (202004J07020040 to XJ Feng), Program of Clinical and Basic Cooperative Research of Anhui Medical University, China (2020skjT043 to XJ Feng), Scientific research project of Health Commission of Fuyang City, Anhui Province (FY2021-125 to XJ Feng) and Scientific Research Fund project of Anhui Medical University (2020xkj030 to Y Jiang), Project of Anhui Medical University Teaching Quality Research (2021xjjyxm49 to XJ Feng), Second Affiliated Hospital of Anhui Medical University-Hefei Institute of Intelligent Machinery, Chinese Academy of Sciences “Chronic Disease Prevention and Control Joint Research Fund” (MBLHJ202006 to Y Liu)."

"The current study was performed in accordance with the ethics standards set out in the 1964 Declaration of Helsinki (revised 2013). This study was approved by the Clinical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University (registration number: SL-LC2019037 (F1). The study protocol was registered with the Chinese Clinical Trial Registry (clinical registration number: ChiCTR2200059431). All methods were carried out in accordance with relevant guidelines and regulations. Of a total of 50 patients, 5 did not meet the inclusion criteria, 4 declined to participate, and 3 were excluded for other reasons. Following the randomization principle, the remaining 38 patients were divided randomly into an iTBS group and a sham group in a ratio of 1:1, using the random number table method after obtaining informed signed consent from the patients or their guardians. The specific methods were as follows: 38 patients with SCI (numbers 1–38) were divided into 2 groups by the principal investigator (PI). The subjects corresponding to these 19 numbers were assigned to 1 group, and the remaining subjects were assigned to another group. The randomization schedule was concealed in a locked cabinet accessed only by the PI and the investigators who administer iTBS. Hence, patients were blind regarding the type of transcranial magnetic stimulation (TMS) they received (real or sham). Neither the participants nor the researchers assessing outcomes were aware of the interventions administered. Subjects were blinded to the experimental assumptions and were not allowed to discuss their experience during the intervention with the researchers or other subjects involved in assessing the results. The study was approved by the Clinical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University (registration number: SL-LC2019037 (F1). The study protocol was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn, Clinical Registration number: ChiCTR2200059431)."