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

U

University Medical Center Groningen (UMCG)

Status

Unknown

Conditions

Cognitive Deficit

Treatments

Device: DBS
Device: NBM-DBS

Study type

Interventional

Funder types

Other

Identifiers

NCT02763397
NL 57011.042.16

Details and patient eligibility

About

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).

Full 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).

Enrollment

13 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

13 participants in 2 patient groups, including a placebo group

NBM-DBS on
Experimental group
Description:
DBS is programmed to stimulate the NbM
Treatment:
Device: NBM-DBS
DBS off
Placebo Comparator group
Description:
DBS is turned off, no stimulation will be exerted
Treatment:
Device: DBS

Trial contacts and locations

0

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Central trial contact

Muhammad Nazmuddin, MD

Data sourced from clinicaltrials.gov

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