Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):121-130. doi: 10.1016/j.ijrobp.2021.08.021. Epub 2021 Aug 25.
We sought to determine whether a more widely accessible, noninvasive, frameless approach to radiosurgical thalamotomy would improve objective measures of refractory essential or parkinsonian tremor without added toxicity compared with reports of frame-based radiosurgery.
We conducted a single-arm pilot observational prospective trial of adult patients with essential or parkinsonian tremor from 2013 to 2019 and report results at 1-year follow-up. Patients were treated with frameless unilateral radiosurgical ablation of the thalamic ventral intermediate nucleus to a maximum dose of 160 Gy. Treatment response was measured by the Fahn-Tolosa-Marin (FTM) tremor rating scale and the Quality of Life in Essential Tremor or Parkinson's Disease Questionnaire obtained before treatment and at 3, 6, 9, and 12 months.
Thirty-three patients, including 23 with essential tremor and 10 with Parkinson's disease, were enrolled. Overall treatment response rate per FTM was 83% (15 of 18) at 6 months. There was a marked improvement in tremor, with an average total FTM reduction of 21% at 3 months (from 46 to 30 points; P = .003) and 41% at 6 months (from 46 to 24 points; P = .001). At 6 months, functional decline had regressed by 54% (from 15 to 7 points; P = .001). Quality of life improved by 57% (P = .001) at 6 months in patients with essential tremor, and patients with Parkinson's disease had unchanged quality of life. At 1-year follow-up, grade 2 neurologic adverse events were observed in 6% (2 of 33) of patients without any grade ≥ 3 events.
Noninvasive, frameless radiosurgical thalamotomy may be a feasible treatment for patients with refractory tremor and demonstrates short-term safety at 1-year follow-up. This pilot study provides promising preliminary descriptions of efficacy, and definitive estimates of long-term safety and benefit require further study with longer follow-up.
我们旨在确定一种更广泛应用、无创、无框架的方法来进行立体定向放射外科丘脑切开术，与基于框架的放射外科治疗报告相比，该方法是否能改善难治性特发性或帕金森震颤的客观指标，而不会增加毒性。
我们进行了一项单臂前瞻性临床试验，纳入了 2013 年至 2019 年间患有特发性或帕金森震颤的成年患者，并在 1 年随访时报告结果。患者接受了单侧无框架立体定向放射外科消融术，丘脑腹侧中间核的最大剂量为 160 Gy。治疗反应通过 Fahn-Tolosa-Marin（FTM）震颤评分量表和在治疗前以及 3、6、9 和 12 个月时获得的特发性震颤或帕金森病生活质量问卷进行测量。
共纳入 33 例患者，其中特发性震颤 23 例，帕金森病 10 例。根据 FTM，6 个月时的总体治疗反应率为 83%（15/18）。震颤明显改善，平均总 FTM 评分在 3 个月时下降 21%（从 46 降至 30 分；P=0.003），在 6 个月时下降 41%（从 46 降至 24 分；P=0.001）。6 个月时，功能下降逆转了 54%（从 15 降至 7 分；P=0.001）。特发性震颤患者的生活质量在 6 个月时提高了 57%（P=0.001），而帕金森病患者的生活质量没有变化。在 1 年随访时，6%（2/33）的患者出现 2 级神经系统不良事件，无任何≥3 级事件。
无创、无框架的立体定向放射外科丘脑切开术可能是治疗难治性震颤患者的一种可行方法，在 1 年随访时具有短期安全性。这项初步研究提供了关于疗效的有前景的初步描述，需要进一步进行长期安全性和益处的研究，以获得更长时间的随访。
