A randomized controlled trial of bilateral subthalamic stimulation in patients with Parkinson’s disease and impulse control disorders – STIMPulseControl

• Applicant: Dr. Steffen Paschen
• Subject Area: Clinical Neurology; Neurosurgery and Neuroradiology
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 512860315

Background: Impulse control disorders and related behavioral disorders (ICBDs) are a common side effect of dopaminergic treatment in Parkinson’s disease with potentially disastrous effects on quality of life. The prevalence of ICBDs in the general Parkinson’s disease population is around 20%. While a decrease of dopaminergic drugs can effectively reduce the severity of ICBDs, there is a high risk of worsening parkinsonism, apathy, and a withdrawal syndrome characterized by psychiatric features. Presently, it is unclear how to treat ICBDs. Aims: Given the urgent need for a successful therapy of ICBDs and the considerable likelihood for success, a randomized-controlled study specifically selecting patients with Parkinson’s disease suffering from ICBDs is needed to determine if ICBDs can successfully be managed with subthalamic nucleus (STN) deep brain stimulation (DBS) and the subsequent reduction in dopaminergic drugs with a better outcome of ICBD and an overall better quality of life as compared to best standard medical treatment. Methods: The trial entails patients with Parkinson’s disease and an ICBD will be randomized (1:1) either to undergo STN DBS combined with best medical treatment (DBS group) or to receive best medical treatment only (control group). The primary outcome will be the change of ICBDs after 12 months, measured with the hyperdopaminergic score of the Ardouin Scale of Behavior in PD. Expected results and relevance for Parkinson’s disease: Results of this trial will provide high-quality evidence, allowing new treatment recommendations when facing ICBDs in Parkinson’s disease, including medical as well as neurosurgical treatment strategies.

• DFG Programme: Clinical Trials
• Co-Investigator: Professor Dr. Günther Deuschl