Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBM-DBS on | Experimental | DBS is programmed to stimulate the NbM |
|
| DBS off | Placebo Comparator | DBS is turned off, no stimulation will be exerted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBM-DBS | Device | DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Nazmuddin, MD | Contact | m.nazmuddin@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Teus van Laar, Prof. Dr. | Department of Neurology, University Medical Center Groningen | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DBS | Device | DBS will be switched off |
|
| 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 |
| Score changes of the symbol digit modality test (SDMT) | 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 |