NCT02924194

Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease

Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (nbM) to Treat Parkinson's Patients With Mild Cognitive Impairment, Amnestic Subtype

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation of the nucleus basalis of Meynert (also called the "nbM") at improving memory in Parkinson's disease patients with mild cognitive impairments and memory difficulties. Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS) therapy for improvement of their motor symptoms and with evidence of mild cognitive impairments and memory difficulties will be enrolled.

Detailed description

This is a prospective, double-blind (patient and neuropsychologist), randomized, cross-over study to evaluate the safety of deep brain stimulation of the nucleus basalis of Meynert (nbM) in Parkinson's disease (PD) patients with mild cognitive impairment (PD-MCI) who are undergoing globus pallidus internus (GPi) stimulation for their motor symptoms. Six patients with PD who are eligible for GPi DBS for improvement of their motor symptoms and who have a clinical diagnosis of PD-MCI (amnestic, single or multiple domain) per Movement Disorder Society (MDS) criteria will be enrolled and implanted with bilateral electrodes in in the nbM in addition to the globus pallidus internus (GPi). Conventional stereotactic implantation of the electrodes will be guided by intraoperative computerized tomography (CT) and magnetic resonance tomography (MRT).

Conditions

• Parkinson's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	stimulation ON	The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.
DEVICE	stimulation OFF	The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2016-10-05
• Last updated: 2021-09-21

Locations

1 site across 1 country: United States