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

Cognitive Deficit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02763397
• Other study ID #: NL 57011.042.16
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 4, 2016
• Start date: May 2016

Study information

• Verified date: May 2016
• Source: University Medical Center Groningen
• Contact: Muhammad Nazmuddin, MD
• Email: m.nazmuddin[@]umcg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 13
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Parkinson Disease

Intervention

Device:
• NBM-DBS
DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM.
• DBS
DBS will be switched off

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3		3 days of the screening phase	No
Secondary	Changes of the power of background EEG frequencies		2 weeks of the crossover trial phase	No
Secondary	Score changes of stroop test		2 weeks of the crossover trial phase	No
Secondary	Score changes of the Trail Making test		2 weeks of the crossover trial phase	No
Secondary	Score changes of the digit span test of Wechsler Adult Intelligence Scale III		2 weeks of the crossover trial phase	No
Secondary	Score changes of the symbol digit modality test (SDMT)		2 weeks of the crossover trial phase	No
Secondary	Score changes of the Hospital Anxiety and Depression Scale		2 weeks of the crossover trial phase	No
Secondary	Score changes of the Apathy Evaluation Scale		2 weeks of the crossover trial phase	No