Clinical trial NCT02763397: Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
Official title: Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Deficit
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
timeFrame: 2 weeks of the crossover trial phase
Secondary outcomes:
measure: Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
timeFrame: 3 days of the screening phase
measure: Changes of the power of background EEG frequencies
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of stroop test
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of the Trail Making test
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of the digit span test of Wechsler Adult Intelligence Scale III
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of the symbol digit modality test (SDMT)
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of the Hospital Anxiety and Depression Scale
timeFrame: 2 weeks of the crossover trial phase
measure: Score changes of the Apathy Evaluation Scale
timeFrame: 2 weeks of the crossover trial phase
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, University Medical Center Groningen
name: Teus van Laar, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: