Marlats Fabienne, Djabelkhir-Jemmi Leila, Azabou Eric, Boubaya Marouane, Pouwels Sjaak, Rigaud Anne-Sophie
Department of Clinical Gerontology, Broca Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Research TEAM EA4468, Paris Descartes University, Paris, France.
Clinical Neurophysiology Laboratory, Department of Physiology, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), INSERM U1173, University of Versailles Saint Quentin en Yvelines, Garches, France.
Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.
Older adults with Mild Cognitive Impairment (MCI) are at high risk of progressing to Alzheimer's disease (AD). Slowing down the effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback (NF) has shown promising results in improving working memory but has never been evaluated in people with MCI. We aim to examine whether NF training can decrease cognitive disorders, targeting memory, attention functions and brain electrical activity in elderly patients with MCI.
In this single-blind, randomized controlled trial (RCT) protocol, we will investigate the effects of two NF training protocols on cognitive performances and on brain electrical activity. Sixty MCI patients will be assigned either to an intervention program or to psycho-pedagogical care as a control condition. Participants in the intervention group will attend 30 sessions of sensorimotor/delta-ratio NF training or beta1/theta-ratio NF training. Neuropsychological assessment, questionnaires and electroencephalography (EEG) assessment parameters will be used as dependent variables in three periods: at baseline (T0), immediately after the last NF training session at 4 months (T1) and at 3-month follow-up (T2). The primary outcome will be the change in attention measured with the Trail Making Test B. Secondary outcome will be the changes in cognitive performance and in EEG activities.
If the results of our study show improvement in cognitive performances of older adults with MCI, this non-invasive, low-cost technique may deserve better consideration as a therapeutic intervention to delay cognitive decline and dementia. Consequently, research in NF will need to review and develop the rigor of its application in gerontology.
ClinicalTrials.gov, ID: NCT03526692 . Registered on 16 May 2018.
患有轻度认知障碍（MCI）的老年人发展为阿尔茨海默病（AD）的风险很高。通过增强大脑可塑性来减缓痴呆症的影响是最突出的挑战之一。神经反馈（NF）在改善工作记忆方面已显示出有前景的结果，但从未在MCI患者中进行过评估。我们旨在研究NF训练是否可以减少MCI老年患者的认知障碍，目标是记忆、注意力功能和脑电活动。
在这个单盲随机对照试验（RCT）方案中，我们将研究两种NF训练方案对认知表现和脑电活动的影响。60名MCI患者将被分配到干预项目或心理教育护理作为对照条件。干预组的参与者将参加30次感觉运动/δ比率NF训练或β1/θ比率NF训练。神经心理学评估、问卷调查和脑电图（EEG）评估参数将在三个时期用作因变量：基线时（T0）、4个月最后一次NF训练 session 后立即（T1）和3个月随访时（T2）。主要结局将是用连线测验B测量的注意力变化。次要结局将是认知表现和EEG活动的变化。
如果我们的研究结果显示MCI老年人的认知表现有所改善，这种非侵入性、低成本的技术可能值得作为一种延缓认知衰退和痴呆的治疗干预措施而得到更好的考虑。因此，NF研究将需要审查和发展其在老年医学中应用的严谨性。
ClinicalTrials.gov，ID：NCT03526692。于2018年5月16日注册。
