Objective: To investigate the efficacy of online Brain and Body Rehab Training (BBRT) (Figure 1), a digital cognitive intervention, in Parkinson’s disease patients with mild cognitive impairment (PD-MCI) and subjective cognitive impairment (PD-SCI).

Background: Digital therapies integrating interactive audio-visual stimuli provide a novel, accessible approach to cognitive rehabilitation. Given the risk of cognitive deterioration in Parkinson’s disease patients with mild (PD-MCI) or subjective cognitive impairment (PD-SCI), evaluating the efficacy of digital cognitive training, such as online Brain and Body Rehab Training (BBRT), is crucial for developing non-pharmacological strategies to support cognitive function.

Method: This study is a 3-year, four-arm, randomized controlled trial designed to recruit 130 PD-MCI patients and 130 PD-SCI patients, aged 55-80, with at least 6 years of education, and no other neurological disorders or serious systemic diseases. Participants will be randomly assigned to either the BBRT intervention group (n =65) or the control group (n=65). The control group will receive regular health education as the BBRT intervention group, while the BBRT intervention group will undergo at least five online BBRT training sessions per week, with each session lasting a minimum of 15 minutes, conducted remotely. Both groups will receive their respective interventions for 36 months, with annual follow-ups to assess the efficacy of BBRT (Figure 2).

Results: The primary outcome of this study will be the total score on the Montreal Cognitive Assessment (MOCA). Secondary outcomes include: (1) Neuropsychological scales: MMSE, PD-CRS, HAMA, HAMD, PDQ-39, and MDS-UPDRS scales. (2) Wearable sensor-based digital biomarkers: Gait, speech, and handwriting analysis. (3) Blood biomarkers: Aβ42, T-tau, P-tau, and neuroinflammatory markers. (4) Neuroimaging outcomes: Structural and functional MRI changes. All participants will be assessed at baseline, and at 12, 24, and 36 months for these outcomes. This study has been registered in the China Clinical Trials Registry (ChiCTR2500097126).

Conclusion: This study will systematically assess the clinical efficacy of BBRT-online intervention in Chinese PD-MCI and PD-SCI patients and provide valuable insights into the mechanisms of non-pharmacological interventions for enhancing cognitive function.

Figure 1. The BBRT-online digital therapeutic.

Figure 2. Flow Chart of the study design.

References: NA

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/a-four-arm-randomized-controlled-trial-on-the-effects-of-multi-dimensional-cognitive-intervention-in-parkinsons-disease-with-mild-and-subjective-cognitive-decline-remind/