Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study

What this Trial Is About

Freezing of gait (FoG) is a challenging symptom in people with Parkinson's disease (PD) that causes falls and loss of independence, significantly reducing quality of life. This study is evaluating two treatment strategies to improve FoG in PD patients who have deep brain stimulation (STN-DBS) but still experience gait difficulties. Researchers want to compare increasing the stimulation intensity versus increasing the dose of levodopa medication, as it is unclear which approach may better help reduce freezing episodes. The study is a randomized, cross-over trial where participants receive two different treatment conditions in separate morning sessions: one with an increased intensity of stimulation (STIM ON plus) and the other with a doubled morning dose of levodopa (MED ON plus). During each session, patients will undergo a standardized walking protocol while wearing inertial sensors to record gait patterns, along with video recordings to assess freezing episodes. Various tests evaluating motor function, cognition, and gait will also be performed. Participants will be closely monitored during and immediately after the walking tasks, with measurements including time spent freezing, gait performance, motor symptom ratings, cognitive tests, and patient impressions of change. Data such as age, sex, and questionnaires about freezing and falls will be collected. This study aims to objectively determine which treatment adjustment better improves freezing of gait, guiding future management of PD patients with STN-DBS. The total study duration and follow-up details are aligned with the testing sessions.

DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease