Lin Chen, Morgan Charity J, Fortenberry E Lane Schlitz, Androulakis X Michelle, McGregor Keith
Birmingham VA Medical Center, Birmingham, AL, United States.
Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL, United States.
Front Neurol. 2025 Apr 24;16:1524004. doi: 10.3389/fneur.2025.1524004. eCollection 2025.
Chronic pain after stroke can occur between 10 and 50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. PSP is caused by the stroke itself and produces moderate or severe pain. It can manifest as new onset or worsening of prior headaches.
EXERT-Stroke was a feasibility pilot 2-arm randomized sham-controlled, double-blind trial at a single center over a 30-day intervention period, followed by a month follow-up. Patients were recruited for this study from July 2022 through June 2024 at the Veterans Hospital. The study protocol was approved by the local institutional review board. The trial was registered with ClinicalTrials.gov (NCT04672044). All potential participants were screened for safety with a graded exercise stress test before randomization. Participants were randomized (1:1) to either active repetitive transcranial magnetic stimulation (rTMS) or sham rTMS. Both arms received the same exercise protocol. The intervention protocol consisted of 10 sessions over a 30-day period of rTMS (sham vs. active) + exercise, where rTMS was delivered prior to each exercise session on the same day. RTMS was aimed at the M1 of the contra-lesional hemisphere. Exercise was delivered on a recumbent bicycle targeting a participant's heart rate reserve. Primary outcomes were intervention feasibility (attendance and tolerance) and safety (adverse events).
Of those consented, one participant was a screen failure, and nine participants were randomized. The average age was 62 years old, 22.2% were female, and 44.4% were Black. For feasibility, five (55.5%) participants were randomized to active rTMS and four (44.4%) were randomized to sham rTMS. Four of the five (80%) active rTMS and two of the four (50.0%) of the sham rTMS completed the final assessment, suggesting that there was no association between treatment assignment and likelihood of completing the study. Importantly, there were no serious adverse events.
This is the first feasibility trial to investigate paired intervention of exercise and rTMS in patients with post-stroke pain. The trial found that the intervention had few safety issues. There was overall positive feedback from participants.
https://clinicaltrials.gov/, identifier NCT04672044.
10%至50%的中风幸存者会出现中风后慢性疼痛。中风后疼痛（PSP）会导致中风幸存者康复过程中出现更多并发症。PSP由中风本身引起，会产生中度或重度疼痛。它可表现为新发头痛或既往头痛加重。
EXERT-Stroke是一项可行性试点双臂随机假对照双盲试验，在一个中心进行，为期30天的干预期，随后进行一个月的随访。2022年7月至2024年6月期间，在退伍军人医院招募患者参与本研究。研究方案经当地机构审查委员会批准。该试验已在ClinicalTrials.gov（NCT04672044）注册。所有潜在参与者在随机分组前均通过分级运动负荷试验进行安全性筛查。参与者被随机（1:1）分为接受主动重复经颅磁刺激（rTMS）或假rTMS。两组均接受相同的运动方案。干预方案包括在30天内进行10次rTMS（假刺激与主动刺激）+运动治疗，其中rTMS在同一天每次运动治疗前进行。rTMS针对患侧对侧半球的M1区。运动通过卧式自行车进行，目标是参与者的心率储备。主要结局是干预的可行性（出勤率和耐受性）和安全性（不良事件）。
在同意参与的人中，1名参与者筛查未通过，9名参与者被随机分组。平均年龄为62岁，22.2%为女性，44.4%为黑人。就可行性而言，5名（55.5%）参与者被随机分配至主动rTMS组，4名（44.4%）被随机分配至假rTMS组。5名主动rTMS参与者中有4名（80%）和4名假rTMS参与者中有2名（50.0%）完成了最终评估，这表明治疗分配与完成研究的可能性之间没有关联。重要的是，没有严重不良事件。
这是第一项研究运动与rTMS联合干预中风后疼痛患者可行性的试验。该试验发现该干预几乎没有安全问题。参与者总体反馈积极。
