Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
1 other identifier
interventional
13
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedMay 5, 2016
May 1, 2016
7 months
April 27, 2016
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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 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 digit span test of Wechsler Adult Intelligence Scale III
2 weeks of the crossover trial phase
- +3 more secondary outcomes
Study Arms (2)
NBM-DBS on
EXPERIMENTALDBS is programmed to stimulate the NbM
DBS off
PLACEBO COMPARATORDBS is turned off, no stimulation will be exerted
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teus van Laar, Prof. Dr.
Department of Neurology, University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 5, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2016
Last Updated
May 5, 2016
Record last verified: 2016-05