Safety of Focused Ultrasound Ablation in Parkinson's Disease: A Meta-Analysis of Randomized Controlled Trials

Magnetic resonance-guided focused ultrasound (MRgFUS) is well-established for the treatment of essential tremor and is emerging as a promising non-incisional treatment for Parkinson's disease (PD). However, its safety in this context is not well established.

We performed a systematic review and meta-analysis to evaluate the incidence of adverse events among patients with medication-refractory PD treated with MRgFUS. PubMed, Embase, Scopus, and Cochrane databases were searched from inception until December 2023. Included studies were peer-reviewed randomized controlled trials (RCTs) comparing MRgFUS to sham-procedures among patients with medication-refractory PD.

Three RCTs comprising 161 patients (MRgFUS n = 115) were included. Dizziness was the most reported adverse event associated with MRgFUS (odds ratio [OR] 4.25; 95 % confidence interval [CI] 1.23-14.64; p = 0.02; I² = 0 %). Pin-site complications (OR 0.52; 95 % CI 0.23-1.20; I² = 0 %) and headache (OR 0.88; 95 % CI 0.19-4.16; I² = 48 %) were also notable. Ablation-related adverse events included gait disturbances (OR 4.53; 95 % CI 0.79-26.07; p = 0.09; I² = 0 %) and facial disturbances (OR 2.93; 95 % CI 0.49-17.51). No significant between-group differences were observed for life-threatening events (OR 1.76, 95 % CI 0.55-5.65; p = 0.35; I² = 0 %).

MRgFUS demonstrated a reasonable safety profile for the treatment of patients with medication-refractory PD. This promising safety profile, combined with its non-incisional nature, supports its potential as a valuable tool for managing refractory PD.