Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease

Not Applicable

• Conditions: Cognitive Deficit
• Interventions: Device: NBM-DBS; Device: DBS

• Registration Number: NCT02763397
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NbM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.

This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).

Detailed Description

The existing DBS setting in patients with GPi DBS, which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NBM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.This study consists of a three-day screening study of the NbM stimulation followed by a two-week, randomized, single-blind, crossover trial. Between the screening study and the crossover trial, one week of washout period will be applied to eliminate potential carryover effect from the previous stimulation.

This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).

Study Timeline

• Study First Submitted: 2016-04-27
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Posted: 2016-05-05
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patients with GPi stimulation, with the NBM within the vicinity of the electric field of at least one DBS electrode.
• Patients should be able to give informed consent
• Patients should be on a stable medication regimen for at least 4 weeks

Exclusion Criteria

• any unstable internal disease
• Subject with significant worsening of motor function during the pilot screening study, which is indicated by an increase of the UPDRS part III score more than 30%, will not continue to the crossover trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NBM-DBS on	NBM-DBS	DBS is programmed to stimulate the NbM
DBS off	DBS	DBS is turned off, no stimulation will be exerted

Primary Outcome Measures

Name	Time	Method
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)	2 weeks of the crossover trial phase

Secondary Outcome Measures

Name	Time	Method
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3	3 days of the screening phase
Changes of the power of background EEG frequencies	2 weeks of the crossover trial phase
Score changes of the Hospital Anxiety and Depression Scale	2 weeks of the crossover trial phase
Score changes of the Apathy Evaluation Scale	2 weeks of the crossover trial phase
Score changes of the digit span test of Wechsler Adult Intelligence Scale III	2 weeks of the crossover trial phase
Score changes of stroop test	2 weeks of the crossover trial phase
Score changes of the Trail Making test	2 weeks of the crossover trial phase
Score changes of the symbol digit modality test (SDMT)	2 weeks of the crossover trial phase