Psychosocial Department, Emma Children's Hospital AMC, room A3-241, Meibergdreef 9, Amsterdam 1105 AZ, The Netherlands.
BMC Cancer. 2012 Dec 6;12:581. doi: 10.1186/1471-2407-12-581.
Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor.
METHODS/DESIGN: Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35) or placebo training (n=35). Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once.
If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning.
ClinicalTrials.gov NCT00961922.
脑肿瘤治疗引起的神经毒性是幸存者神经认知能力下降的主要原因。研究表明,神经反馈可能增强神经认知功能。本文介绍了 PRISMA 研究的方案,这是一项随机对照试验,旨在研究神经反馈改善脑肿瘤治疗后儿童神经认知功能的疗效。
方法/设计:将在随机对照双盲试验中比较神经反馈与安慰剂训练的疗效。共招募 70 名年龄在 8 至 18 岁之间的脑肿瘤幸存者。纳入标准还包括 caregiver 报告的神经认知问题和治疗结束后两年以上。将一组 35 名健康的兄弟姐妹纳入对照组。根据 qEEG,患者将被分配到三种治疗方案之一。此后,患者将被随机分配接受神经反馈训练(n=35)或安慰剂训练(n=35)。将使用神经认知测试和向患者、护理人员和教师发放的问卷来评估干预前后以及 6 个月随访时的功能。兄弟姐妹将接受相同的测试和问卷一次。
如果神经反馈对儿科脑肿瘤幸存者有效,这将是改善神经认知和心理社会功能的稀缺干预措施的一个有价值的补充。
ClinicalTrials.gov NCT00961922。