Randomized control clinical trial to assess the effect of meditation on selected clinical outcomes in patients with Parkinson’s disease

Abstract

Background: Parkinson’s disease (PD) is the second most common neurodegenerative disorder, characterized by progressive loss of dopaminergic neurons, leading to both motor and non-motor symptoms. Although dopaminergic therapy is the current goldstandard therapy in symptomatic management, it does not alter disease progression. Meditation, a complementary therapy, has shown promise in alleviating motor symptoms and improving neuroplasticity, but evidence on its effects on non-motor symptoms remains inconclusive. This randomized controlled trial (RCT) is designed to evaluate the impact of a meditation-based intervention on both motor and non-motor symptoms in patients with PD.Methods: This open-label, parallel-group, randomized clinical trial will be conducted at the National Hospital of Sri Lanka, a tertiary care center. Eligible participants, diagnosed with PD and classified in Hoehn and Yahr stages I–III, will be randomized into two groups: a meditation intervention group and a waitlisted control group receiving usual care. The intervention will include an 8-week meditation program with guided weekly sessions. Outcomes will be assessed using various scales: motor symptoms (SPES/SCOPA-Motor), non-motor symptoms (SENS-PD), cognitive function (RBANS), quality of life (PDQ-39), and gait performance (TUG test). Additionally, nerve conduction studies will evaluate peripheral motor nerve function.Discussion: This study aims to provide evidence on the effects of meditation on motor and non-motor symptoms in PD, which could support the integration of meditation into PD management protocols. The trial will explore the potential neuroplastic changes and improvements in quality of life mediated by meditation, providing further insights into non-pharmacological treatment options for PD patients.