Chen Lin, Charity J Morgan, E Lane Schlitz Fortenberry, X Michelle Androulakis, Keith McGregor
{"title":"使用联合运动和神经刺激治疗卒中后疼痛的随机临床试验的安全性和可行性：ert -卒中研究。","authors":"Chen Lin, Charity J Morgan, E Lane Schlitz Fortenberry, X Michelle Androulakis, Keith McGregor","doi":"10.3389/fneur.2025.1524004","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/, identifier NCT04672044.</p>","PeriodicalId":12575,"journal":{"name":"Frontiers in Neurology","volume":"16 ","pages":"1524004"},"PeriodicalIF":2.7000,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060257/pdf/","citationCount":"0","resultStr":"{\"title\":\"The safety and feasibility of a pilot randomized clinical trial using combined exercise and neurostimulation for post-stroke pain: the EXERT-Stroke study.\",\"authors\":\"Chen Lin, Charity J Morgan, E Lane Schlitz Fortenberry, X Michelle Androulakis, Keith McGregor\",\"doi\":\"10.3389/fneur.2025.1524004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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. 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The safety and feasibility of a pilot randomized clinical trial using combined exercise and neurostimulation for post-stroke pain: the EXERT-Stroke study.
Background: 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.
Methods: 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).
Results: 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.
Conclusion: 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.
期刊介绍：
The section Stroke aims to quickly and accurately publish important experimental, translational and clinical studies, and reviews that contribute to the knowledge of stroke, its causes, manifestations, diagnosis, and management.
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