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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02924194
• Other study ID #: PHX-16-0141-30-06
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 15, 2021

Study information

• Verified date: September 2021
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Informed consent signed by the subject.
• Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria
• Diagnosis of PD-MCI, amnestic subtype per MDS criteria (Level II assessment)
• DBS candidate for GPi targeting per the consensus committee
• 50 - 75 years of age
• Primary English speaking
• Minimum of 10 years of education
• Motorically and cognitively capable of completing evaluations and consent
• Medically cleared for surgery and anesthesia
• Subject must be on stable doses of any medication used to treat PD or cognition for 3 months prior to study entry
• Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery -

Exclusion Criteria:

• Dementia per DSM-V criteria
• Condition precluding MRI
• History of supraspinal CNS disease other than PD
• Medical condition or required medication compromising cognition
• Alcohol use of more than 4 drinks per day
• Currently uncontrolled moderate-severe depression (BDI>20)
• History of suicide attempt in the year preceding study screening
• History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
• Use of cholinesterase inhibitor
• Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
• Subjects with a history of seizure disorder
• Subjects who have made a suicide attempt within the prior year,
• Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
• Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
• Subjects who are pregnant or nursing.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	Barrow Neurological Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety of DBS-nbM	Evaluate safety through collection of adverse events at weeks 4, 16, 28, 52 and months 24 and 36.	Month 36
Secondary	Stability or improvement of cognitive symptoms	Administration of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) administered at Week 52 and Months 24 and 36. A clinically meaningful change is indicated by a 4 point change in ADAS-Cog.	Month 36