Cognitive DeficitNCT02763397
Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease
A study testing NBM-DBS and DBS in people with Cognitive Deficit, run by University Medical Center Groningen.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive Deficit
- What is being tested?
- NBM-DBS and DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Muhammad Nazmuddin, MD contact
About this study
Official title: Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
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).
Read the 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).
- Conditions
- Cognitive Deficit
- Being tested
- NBM-DBS, DBS
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBM-DBSDevice
DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM.
DBSDevice
DBS will be switched off
| Study group | Role | What they receive |
|---|---|---|
| NBM-DBS on | Experimental | DBS is programmed to stimulate the NbM Receives: Device: NBM-DBS |
| DBS off | Placebo comparator | DBS is turned off, no stimulation will be exerted Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
Measured: 2 weeks of the crossover trial phase
Secondary outcomes (8)
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
Measured: 3 days of the screening phase
Changes of the power of background EEG frequencies
Measured: 2 weeks of the crossover trial phase
Score changes of stroop test
Measured: 2 weeks of the crossover trial phase
Score changes of the Trail Making test
Measured: 2 weeks of the crossover trial phase
Score changes of the digit span test of Wechsler Adult Intelligence Scale III
Measured: 2 weeks of the crossover trial phase
Score changes of the symbol digit modality test (SDMT)
Measured: 2 weeks of the crossover trial phase
Score changes of the Hospital Anxiety and Depression Scale
Measured: 2 weeks of the crossover trial phase
Score changes of the Apathy Evaluation Scale
Measured: 2 weeks of the crossover trial phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teus van Laar, University Medical Center Groningen
- Investigators
- Teus van Laar, Prof. Dr., Principal investigator, Department of Neurology, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763397
- Sponsor's protocol ID
- NL 57011.042.16
- Status last verified
- May 2016
- First submitted
- 27 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT02763397
- Acronym / sponsor ID
- NL 57011.042.16
- Conditions
- Cognitive Deficit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBM-DBS on | Experimental | Device: NBM-DBSDBS is programmed to stimulate the NbM |
| DBS off | Placebo comparator | Device: DBSDBS is turned off, no stimulation will be exerted |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBM-DBSDBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM. | Device | NBM-DBS on |
| DBSDBS will be switched off | Device | DBS off |
Primary outcome
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
Time frame: 2 weeks of the crossover trial phase
8 secondary outcomes
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3
Time frame: 3 days of the screening phase
Changes of the power of background EEG frequencies
Time frame: 2 weeks of the crossover trial phase
Score changes of stroop test
Time frame: 2 weeks of the crossover trial phase
Score changes of the Trail Making test
Time frame: 2 weeks of the crossover trial phase
Score changes of the digit span test of Wechsler Adult Intelligence Scale III
Time frame: 2 weeks of the crossover trial phase
Score changes of the symbol digit modality test (SDMT)
Time frame: 2 weeks of the crossover trial phase
Score changes of the Hospital Anxiety and Depression Scale
Time frame: 2 weeks of the crossover trial phase
Score changes of the Apathy Evaluation Scale
Time frame: 2 weeks of the crossover trial phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Nazmuddin, MD contact
Teus van Laar, Prof. Dr. principal investigator
Department of Neurology, University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing NBM-DBS and DBS in people with Cognitive Deficit, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nazmuddin, MD (m.nazmuddin@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG) (time frame: 2 weeks of the crossover trial phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.