COGTIPS: a double-blind randomized active controlled trial protocol to study the effect of home-based, online cognitive training on cognition and brain networks in Parkinson’s disease

Abstract

Background Cognitive dysfunction is highly prevalent in Parkinson’s disease (PD) and a large proportion of patients eventually develops PD-related dementia. Currently, no effective treatment is available. Cognitive training is effective in relieving cognitive dysfunctions in several –neurodegenerative– diseases, and earlier small-scale trials have shown positive results for PD. In this randomized controlled trial, we assess the efficacy of online home-based cognitive training, its long-term effects, as well as the underlying neural correlates in a large group of PD patients. Methods In this double-blind randomized controlled trial we will include 140 non-demented patients with idiopathic PD that experience significant subjective cognitive complaints. Participants will be randomized into a cognitive training group and an active control group. In both groups, participants will individually perform an online home-based intervention for eight weeks, three times a week during 45 min. The cognitive training consists of thirteen games that focus on executive functions, attention and processing speed with an adaptive difficulty. The active control comprises three games that keep participants cognitively engaged without a training component. Participants will be subjected to extensive neuropsychological assessments at baseline and after the intervention, and at six months, one year and two years of follow-up. A subset of participants (40 in each treatment condition) will undergo structural and functional magnetic resonance imaging. The primary outcome of this study is the performance on the Tower of London task. Secondary outcomes are objective and subjective cognitive functioning, conversion to PD-related mild cognitive impairment or dementia, functional and structural connectivity and network topological indices measured with magnetic resonance imaging. None of the outcome measures are part of the cognitive training program. Data will be analyzed using multivariate mixed-model analyses and odds ratios. Discussion This study is a large-scale cognitive training study in PD patients that evaluates the efficacy in relieving cognitive dysfunction, and the underlying mechanisms. The strengths of this study are the large sample size, the long follow-up period and the use of neuroimaging in a large subsample. The study is expected to have a low attrition and a high compliance rate given the home-based and easily-accessible intervention in both conditions. Trial registration ClinicalTrials.gov ID NCT02920632 . Registered September 30, 2016. Electronic supplementary material The online version of this article (10.1186/s12883-019-1403-6) contains supplementary material, which is available to authorized users.

Mapping Behavioral Health Serious Game Interventions for Adults With Chronic Illness: Scoping Review

“…Within the 34% (13/38) studies that cited a theoretical framework, frameworks varied in their application to the intervention and variables. Most frameworks focused on mechanics of specific interventions (simulation theory [ 33 ], cognitive training reorganization on brain network infrastructure [ 34 ], spaced education [ 35 ], neurofeedback for pain control [ 36 ], integrative rehabilitation [ 31 ], and self-management [ 33 , 37 ]). Other frameworks focused on intervention development (intervention mapping approach [ 38 ] and Gagne’s instruction strategies [ 39 ]) and rationales for serious game features (behavioral economics [ 40 , 41 ], dual-task training [ 32 ], narrative transportation theory [ 42 ], self-determination theory [ 42 - 44 ], and behavior change theory [ 43 , 44 ]).…”

Effect of Eight-Week Online Cognitive Training in Parkinson’s Disease: A Randomized Controlled Trial

“…Our results were contrary to our expectation that an intervention in earlystage PDwhen compensatory neural mechanisms may still be able to counteract progressive PD pathologywould be more efficacious. [13] The potential larger efficacy of CT in PD-D patients awaits replication in a larger sample as our PD-D sub-group was small.…”

“…At baseline (T0), after training (T1, at approximately nine weeks) and at follow-up (T2, approximately six-months after training) patients underwent an extensive assessment that included neuropsychological tests, questionnaires and interviews (see below and the protocol article [13] for details).…”

“…A detailed study protocol article was published before the end of the recruitment period and de-blinding, also including the results of a pilot feasibility study. [13] This trial was prospectively registered at ClinicalTrials.gov, identifier NCT02920632 (September 30, 2016) and the CONSORT checklist is provided as Supplementary Material.…”

“…[8,12] In this report we present the primary results of the COGnitive Training In Parkinson Study (COGTIPS). [13] We hypothesized, based on earlier research, that CT would predominantly improve executive function (primary outcome), but also other cognitive functions, i.e. working memory and processing speed.…”