Parkinson's DiseaseNCT02924194

Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease

A study testing stimulation ON and stimulation OFF in people with Parkinson's Disease and Mild Cognitive Impairment, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Parkinson's Disease, Mild Cognitive Impairment
What is being tested?: stimulation ON and stimulation OFF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Sep 2016to 15 Apr 2021
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent signed by the subject.
Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria
Diagnosis of PD-MCI, amnestic subtype per MDS criteria (Level II assessment)
DBS candidate for GPi targeting per the consensus committee
50 - 75 years of age
Primary English speaking

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Minimum of 10 years of education
Motorically and cognitively capable of completing evaluations and consent
Medically cleared for surgery and anesthesia
Subject must be on stable doses of any medication used to treat PD or cognition for 3 months prior to study entry
Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery -

Who cannot join

Dementia per DSM-V criteria
Condition precluding MRI
History of supraspinal CNS disease other than PD
Medical condition or required medication compromising cognition
Alcohol use of more than 4 drinks per day
Currently uncontrolled moderate-severe depression (BDI>20)

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History of suicide attempt in the year preceding study screening
History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
Use of cholinesterase inhibitor
Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
Subjects with a history of seizure disorder
Subjects who have made a suicide attempt within the prior year,
Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
Subjects who are pregnant or nursing.

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85205-6118

Other trials in United States

About this study

Official title: Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (nbM) to Treat Parkinson's Patients With Mild Cognitive Impairment, Amnestic Subtype

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation of the nucleus basalis of Meynert (also called the "nbM") at improving memory in Parkinson's disease patients with mild cognitive impairments and memory difficulties. Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS) therapy for improvement of their motor symptoms and with evidence of mild cognitive impairments and memory difficulties will be enrolled.

Read the detailed description

This is a prospective, double-blind (patient and neuropsychologist), randomized, cross-over study to evaluate the safety of deep brain stimulation of the nucleus basalis of Meynert (nbM) in Parkinson's disease (PD) patients with mild cognitive impairment (PD-MCI) who are undergoing globus pallidus internus (GPi) stimulation for their motor symptoms. Six patients with PD who are eligible for GPi DBS for improvement of their motor symptoms and who have a clinical diagnosis of PD-MCI (amnestic, single or multiple domain) per Movement Disorder Society (MDS) criteria will be enrolled and implanted with bilateral electrodes in in the nbM in addition to the globus pallidus internus (GPi). Conventional stereotactic implantation of the electrodes will be guided by intraoperative computerized tomography (CT) and magnetic resonance tomography (MRT).

Conditions: Parkinson's Disease, Mild Cognitive Impairment
Being tested: stimulation ON, stimulation OFF
Medical subject headings: Parkinson Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stimulation ONDevice
The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.
stimulation OFFDevice
The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.

Study groups in NCT02924194
Study group	Role	What they receive
nbM stimulation ON for 3 months (GPi also on)	Experimental	Subjects will undergo activation of GPi and nbM electrodes The GPi's will be stimulated to achieve improvement in motor function. There is a double blind evaluation of DBS-nbM stimulation. Subjects will be those with nbM stimulation ON for a period of 3 months (GPi also on). No usual treatment is withheld. PD drug doses will be stable unless disabling dyskinesias warrants a reduction of medication. After initial 3 months period of stimulation subject will undergo a repeat of neuropsychological testing and Motor Unified Parkinson's Disease Rating Scale (UPDRS) rating prior to switching group assignment (cross-over). There will be a 2 day wash-out period of nbM stimulation for all subjects (both the On and Off groups) in order to minimize subject bias. Then, the subjects will undergo additional brief neuropsychological testing to asses for carry over effects. The subjects will then be switched to the alternate nbM stimulation group (cross-over) from their previous 3 month period. Receives: Device: stimulation ON
nbM stimulation OFF for 3 months (GPi is on)	Experimental	Subjects will undergo activation of GPi and nbM electrodes The GPi's will be stimulated to achieve improvement in motor function. There is a double blind evaluation of DBS-nbM stimulation. Subjects will be those with nbM stimulation OFF for a period of 3 months (GPi is on). No usual treatment is withheld. PD drug doses will be stable during blinded parts of the assessment unless disabling dyskinesias warrants a reduction of medication. After initial 3 months period of stimulation subject will undergo a repeat of neuropsychological testing and Motor UPDRS rating prior to switching group assignment (cross-over). There will be a 2 day wash-out period of nbM stimulation for all subjects (both the On and Off groups) in order to minimize subject bias. Then, the subjects will undergo additional brief neuropsychological testing to asses for carry over effects. The subjects will then be switched to the alternate nbM stimulation group (cross-over) from their previous 3 month period. Receives: Device: stimulation OFF

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate safety of DBS-nbM
Evaluate safety through collection of adverse events at weeks 4, 16, 28, 52 and months 24 and 36.
Measured: Month 36

Secondary outcomes (1)

Stability or improvement of cognitive symptoms
Administration of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) administered at Week 52 and Months 24 and 36. A clinically meaningful change is indicated by a 4 point change in ADAS-Cog.
Measured: Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201615 Apr 2021

First posted5 Oct 2016 (estimated)
Study startSep 2016
Primary completion15 Apr 2021
Study completion15 Apr 2021

Why it stopped: The study was halted prematurely due to lack of interested participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02924194
Sponsor's protocol ID: PHX-16-0141-30-06
Status last verified: Sep 2021
First submitted: 30 Sep 2016
Last updated: 21 Sep 2021
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2021. 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) to Treat Parkinson's Patients With Mild Cognitive Impairment, Amnestic Subtype
ClinicalTrials.gov ID: NCT02924194
Acronym / sponsor ID: PHX-16-0141-30-06
Conditions: Parkinson's Disease, Mild Cognitive Impairment
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was halted prematurely due to lack of interested participants.
Enrolment: 3 participants (actual)
Lead sponsor: St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
Collaborators: Barrow Neurological Foundation
Study start: Sep 2016
Primary completion: 15 Apr 2021 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 5 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
nbM stimulation ON for 3 months (GPi also on)	Experimental	Device: stimulation ONSubjects will undergo activation of GPi and nbM electrodes The GPi's will be stimulated to achieve improvement in motor function. There is a double blind evaluation of DBS-nbM stimulation. Subjects will be those with nbM stimulation ON for a period of 3 months (GPi also on). No usual treatment is withheld. PD drug doses will be stable unless disabling dyskinesias warrants a reduction of medication. After initial 3 months period of stimulation subject will undergo a repeat of neuropsychological testing and Motor Unified Parkinson's Disease Rating Scale (UPDRS) rating prior to switching group assignment (cross-over). There will be a 2 day wash-out period of nbM stimulation for all subjects (both the On and Off groups) in order to minimize subject bias. Then, the subjects will undergo additional brief neuropsychological testing to asses for carry over effects. The subjects will then be switched to the alternate nbM stimulation group (cross-over) from their previous 3 month period.
nbM stimulation OFF for 3 months (GPi is on)	Experimental	Device: stimulation OFFSubjects will undergo activation of GPi and nbM electrodes The GPi's will be stimulated to achieve improvement in motor function. There is a double blind evaluation of DBS-nbM stimulation. Subjects will be those with nbM stimulation OFF for a period of 3 months (GPi is on). No usual treatment is withheld. PD drug doses will be stable during blinded parts of the assessment unless disabling dyskinesias warrants a reduction of medication. After initial 3 months period of stimulation subject will undergo a repeat of neuropsychological testing and Motor UPDRS rating prior to switching group assignment (cross-over). There will be a 2 day wash-out period of nbM stimulation for all subjects (both the On and Off groups) in order to minimize subject bias. Then, the subjects will undergo additional brief neuropsychological testing to asses for carry over effects. The subjects will then be switched to the alternate nbM stimulation group (cross-over) from their previous 3 month period.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Informed consent signed by the subject.
Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria
Diagnosis of PD-MCI, amnestic subtype per MDS criteria (Level II assessment)
DBS candidate for GPi targeting per the consensus committee
50 - 75 years of age

Key exclusion criteria (15 listed)

Dementia per DSM-V criteria
Condition precluding MRI
History of supraspinal CNS disease other than PD
Medical condition or required medication compromising cognition
Alcohol use of more than 4 drinks per day

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
stimulation ONThe system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.	Device	nbM stimulation ON for 3 months (GPi also on)
stimulation OFFThe system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as "the DBS System". The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor.	Device	nbM stimulation OFF for 3 months (GPi is on)

Primary outcome

Evaluate safety of DBS-nbM
Time frame: Month 36
Evaluate safety through collection of adverse events at weeks 4, 16, 28, 52 and months 24 and 36.

1 secondary outcome

Stability or improvement of cognitive symptoms
Time frame: Month 36

Results and safety

The study was stopped early (reason given: The study was halted prematurely due to lack of interested participants.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Individual participant dataSharing planned: No

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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.

Francisco A Ponce, MD principal investigator

Barrow Brain and Spine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study was stopped early (reason given: The study was halted prematurely due to lack of interested participants.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate safety of DBS-nbM (time frame: Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924194.

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 21 Sep 2021.