Parkinson Disease2T-DBSNCT04571112
GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
A study testing NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) in people with Parkinson Disease and Memory Disorders, run by University of Toronto at 1 site in Canada.
Trial summary
This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's disease (PD). Globus pallidus interna (GPi) stimulation is an established treatment for the motor symptoms in PD, but it does not treat the cognitive symptoms that can also be seen in this condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Memory Disorders
- What is being tested?
- NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2017to 1 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PD-MCI that affects multiple cognitive domains (including memory, visuo-spatial deficits etc.). diagnosis based on a comprehensive neuropsychological assessment (gold-standard) allowing the application of Level II MDS diagnostic criteria (Dubois et al. 2007)
- PD fulfilling standard criteria for bilateral GPi DBS surgery
- Patient's ability to provide informed consent and comply with study protocol.
Who cannot join
- Severe Parkinson's disease dementia, preventing completion of the neuropsychological assessment, compliance with the study protocol, or ability to provide informed consent.
- Inability to be fluent in English.
- Unstable dose of any cognitive enhancing medication.
- Presence of other neurological disorders, severe active psychiatric conditions or previous brain surgery.
- Other conditions contraindicating DBS, PET scanning or MRI scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's disease (PD). Globus pallidus interna (GPi) stimulation is an established treatment for the motor symptoms in PD, but it does not treat the cognitive symptoms that can also be seen in this condition. It is theorized that we can improve cognitive dysfunction by stimulating a part of the brain called the nucleus basalis of Meynert (NBM), which releases a chemical (acetylcholine) and plays a role in memory and attention. By using a novel DBS system (Vercise device) with 2 electrodes that are designed to stimulate the GPi and NBM, we can potentially target the motor and cognitive symptoms of PD with a single intervention.
Read the detailed description
Neuronal loss within the cholinergic nucleus basalis of Meynert (NBM) correlates with cognitive decline in dementing disorders such as Alzheimer's disease and Parkinson's disease (PD). Deep Brain Stimulation targeting the Globus Pallidus interna (GPi) is an established treatment for the motor symptoms in Parkinson's Disease, and stimulating the NBM is believed to stimulate cognitive function. Targeting these two regions was previously impossible because they require different frequency stimulations, but recent developments in DBS technology allow for the dual stimulation of these nuclei at different frequencies.
This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS. The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms.
- Conditions
- Parkinson Disease, Memory Disorders
- Being tested
- NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
- Medical subject headings
- Parkinson Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)Device
This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.
| Study group | Role | What they receive |
|---|---|---|
| NBM ON | Experimental | The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.
The NBM ON arm will have constant NBM stimulation for 8 weeks. Receives: Device: NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) |
| NBM OFF | Sham comparator | The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.
The NBM OFF arm will have NBM stimulation turned off for 8 weeks. Receives: Device: NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition after GPi/NBM DBS
This will be measured by the ADAS-Cog 13, verbal fluency test and sustained attention task.
Measured: at baseline and 6, 14, 22, 30 and 52 weeks post surgery
Change in motor function (UPDRS)GPi/NBM DBS
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 65 item assessment of both motor and non-motor symptoms associated with Parkinson's Disease. Each symptom is rated on a 5-point scale (from 0 to 4), and the maximum total score is 199, indicating severe impairment from parkinson's disease.
Measured: at baseline and 6, 14, 22, 30 and 52 weeks post surgery
To assess the occurrence of adverse events from GPi/NBM DBS and occurrence of adverse events.
We define an adverse event (AE) as any untoward medical occurrence that occurs in the course of this study whether or not considered related to the study device, study procedures or study requirements that is identified or worsens during the study.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
To assess the impact on health-related quality-of-life and various non-motor symptoms of PD
This is measured by the Parkinson's Disease Questionnaire, with a score range from 0 (never have difficulty) to 100 (always have difficulty), and with lower scores reflecting a better quality of life
Measured: 1 year
To use neuroimaging biomarkers (MEG and FDG-PET) to examine localized effects of NBM stimulation
Region of interest analysis will be used to determine the localized effects of NBM in the surrounding structures and cortex for both MEG and PET imaging.
Measured: with NBM turned on and off, 22 and 30 weeks after surgery respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start4 Dec 2017
- Primary completion1 Oct 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Model description
- To target both the NBM and GPi in a single trajectory, using the Vercise system (Boston Scientific, Marlborough, Massachusetts, US) which is now approved for human use in Canada. This system includes a novel 8-contact electrode and an IPG system with 16 independent power sources allowing the so-called 'Multiple Independent Current Control' (MICC) that permits concurrent high- and low-frequency stimulation, as well as a variety of amplitudes and pulse widths independently controlled at each stimulated region.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
- Investigators
- Alfonso Fasano, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571112
- Sponsor's protocol ID
- 17-5400-B
- Acronym
- 2T-DBS
- Status last verified
- Nov 2022
- First submitted
- 12 Sep 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bentley P, Driver J, Dolan RJ. Cholinergic modulation of cognition: insights from human pharmacological functional neuroimaging. Prog Neurobiol. 2011 Sep 1;94(4):360-88. doi: 10.1016/j.pneurobio.2011.06.002. Epub 2011 Jun 17.
PubMed 21708219Bosboom JL, Stoffers D, Stam CJ, Berendse HW, Wolters ECh. Cholinergic modulation of MEG resting-state oscillatory activity in Parkinson's disease related dementia. Clin Neurophysiol. 2009 May;120(5):910-5. doi: 10.1016/j.clinph.2009.03.004. Epub 2009 Apr 21.
PubMed 19386543Combs HL, Folley BS, Berry DT, Segerstrom SC, Han DY, Anderson-Mooney AJ, Walls BD, van Horne C. Cognition and Depression Following Deep Brain Stimulation of the Subthalamic Nucleus and Globus Pallidus Pars Internus in Parkinson's Disease: A Meta-Analysis. Neuropsychol Rev. 2015 Dec;25(4):439-54. doi: 10.1007/s11065-015-9302-0. Epub 2015 Oct 12.
PubMed 26459361Di Santo SG, Prinelli F, Adorni F, Caltagirone C, Musicco M. A meta-analysis of the efficacy of donepezil, rivastigmine, galantamine, and memantine in relation to severity of Alzheimer's disease. J Alzheimers Dis. 2013;35(2):349-61. doi: 10.3233/JAD-122140.
PubMed 23411693Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
PubMed 18098298Fasano A, Appel-Cresswell S, Jog M, Zurowkski M, Duff-Canning S, Cohn M, Picillo M, Honey CR, Panisset M, Munhoz RP. Medical Management of Parkinson's Disease after Initiation of Deep Brain Stimulation. Can J Neurol Sci. 2016 Sep;43(5):626-34. doi: 10.1017/cjn.2016.274.
PubMed 27670207Freund HJ, Kuhn J, Lenartz D, Mai JK, Schnell T, Klosterkoetter J, Sturm V. Cognitive functions in a patient with Parkinson-dementia syndrome undergoing deep brain stimulation. Arch Neurol. 2009 Jun;66(6):781-5. doi: 10.1001/archneurol.2009.102.
PubMed 19506141Gratwicke J, Jahanshahi M, Foltynie T. Parkinson's disease dementia: a neural networks perspective. Brain. 2015 Jun;138(Pt 6):1454-76. doi: 10.1093/brain/awv104. Epub 2015 Apr 16.
PubMed 25888551Kuhn J, Hardenacke K, Lenartz D, Gruendler T, Ullsperger M, Bartsch C, Mai JK, Zilles K, Bauer A, Matusch A, Schulz RJ, Noreik M, Buhrle CP, Maintz D, Woopen C, Haussermann P, Hellmich M, Klosterkotter J, Wiltfang J, Maarouf M, Freund HJ, Sturm V. Deep brain stimulation of the nucleus basalis of Meynert in Alzheimer's dementia. Mol Psychiatry. 2015 Mar;20(3):353-60. doi: 10.1038/mp.2014.32. Epub 2014 May 6.
PubMed 24798585Kumar R, Lang AE, Rodriguez-Oroz MC, Lozano AM, Limousin P, Pollak P, Benabid AL, Guridi J, Ramos E, van der Linden C, Vandewalle A, Caemaert J, Lannoo E, van den Abbeele D, Vingerhoets G, Wolters M, Obeso JA. Deep brain stimulation of the globus pallidus pars interna in advanced Parkinson's disease. Neurology. 2000;55(12 Suppl 6):S34-9.
PubMed 11188973Liu AK, Chang RC, Pearce RK, Gentleman SM. Nucleus basalis of Meynert revisited: anatomy, history and differential involvement in Alzheimer's and Parkinson's disease. Acta Neuropathol. 2015 Apr;129(4):527-40. doi: 10.1007/s00401-015-1392-5. Epub 2015 Jan 30.
PubMed 25633602McGaughy J, Kaiser T, Sarter M. Behavioral vigilance following infusions of 192 IgG-saporin into the basal forebrain: selectivity of the behavioral impairment and relation to cortical AChE-positive fiber density. Behav Neurosci. 1996 Apr;110(2):247-65. doi: 10.1037//0735-7044.110.2.247.
PubMed 8731052Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
PubMed 9236948Pagano G, Rengo G, Pasqualetti G, Femminella GD, Monzani F, Ferrara N, Tagliati M. Cholinesterase inhibitors for Parkinson's disease: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):767-73. doi: 10.1136/jnnp-2014-308764. Epub 2014 Sep 15.
PubMed 25224676Park M, Hood MM, Shah RC, Fogg LF, Wyatt JK. Sleepiness, parkinsonian features and sustained attention in mild Alzheimer's disease. Age Ageing. 2012 Nov;41(6):765-70. doi: 10.1093/ageing/afs084. Epub 2012 Jun 27.
PubMed 22743151
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04571112
- Acronym / sponsor ID
- 2T-DBS / 17-5400-B
- Conditions
- Parkinson Disease, Memory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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.
This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's disease (PD). Globus pallidus interna (GPi) stimulation is an established treatment for the motor symptoms in PD, but it does not treat the cognitive symptoms that can also be seen in this condition. It is theorized that we can improve cognitive dysfunction by stimulating a part of the brain called the nucleus basalis of Meynert (NBM), which releases a chemical (acetylcholine) and plays a role in memory and attention. By using a novel DBS system (Vercise device) with 2 electrodes that are designed to stimulate the GPi and NBM, we can potentially target the motor and cognitive symptoms of PD with a single intervention.
Detailed description
Neuronal loss within the cholinergic nucleus basalis of Meynert (NBM) correlates with cognitive decline in dementing disorders such as Alzheimer's disease and Parkinson's disease (PD). Deep Brain Stimulation targeting the Globus Pallidus interna (GPi) is an established treatment for the motor symptoms in Parkinson's Disease, and stimulating the NBM is believed to stimulate cognitive function. Targeting these two regions was previously impossible because they require different frequency stimulations, but recent developments in DBS technology allow for the dual stimulation of these nuclei at different frequencies.
This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS. The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To target both the NBM and GPi in a single trajectory, using the Vercise system (Boston Scientific, Marlborough, Massachusetts, US) which is now approved for human use in Canada. This system includes a novel 8-contact electrode and an IPG system with 16 independent power sources allowing the so-called 'Multiple Independent Current Control' (MICC) that permits concurrent high- and low-frequency stimulation, as well as a variety of amplitudes and pulse widths independently controlled at each stimulated region.
| Arm | Type | Receives |
|---|---|---|
| NBM ON | Experimental | Device: NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over. The NBM ON arm will have constant NBM stimulation for 8 weeks. |
| NBM OFF | Sham comparator | Device: NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over. The NBM OFF arm will have NBM stimulation turned off for 8 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PD-MCI that affects multiple cognitive domains (including memory, visuo-spatial deficits etc.). diagnosis based on a comprehensive neuropsychological assessment (gold-standard) allowing the application of Level II MDS diagnostic criteria (Dubois et al. 2007)
- PD fulfilling standard criteria for bilateral GPi DBS surgery
- Patient's ability to provide informed consent and comply with study protocol.
Key exclusion criteria (5 listed)
- Severe Parkinson's disease dementia, preventing completion of the neuropsychological assessment, compliance with the study protocol, or ability to provide informed consent.
- Inability to be fluent in English.
- Unstable dose of any cognitive enhancing medication.
- Presence of other neurological disorders, severe active psychiatric conditions or previous brain surgery.
- Other conditions contraindicating DBS, PET scanning or MRI scanning.
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 stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks. | Device | NBM OFF, NBM ON |
Primary outcome
Change in cognition after GPi/NBM DBS
Time frame: at baseline and 6, 14, 22, 30 and 52 weeks post surgery
This will be measured by the ADAS-Cog 13, verbal fluency test and sustained attention task.
Change in motor function (UPDRS)GPi/NBM DBS
Time frame: at baseline and 6, 14, 22, 30 and 52 weeks post surgery
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 65 item assessment of both motor and non-motor symptoms associated with Parkinson's Disease. Each symptom is rated on a 5-point scale (from 0 to 4), and the maximum total score is 199, indicating severe impairment from parkinson's disease.
To assess the occurrence of adverse events from GPi/NBM DBS and occurrence of adverse events.
Time frame: through study completion, an average of 1 year
We define an adverse event (AE) as any untoward medical occurrence that occurs in the course of this study whether or not considered related to the study device, study procedures or study requirements that is identified or worsens during the study.
2 secondary outcomes
To assess the impact on health-related quality-of-life and various non-motor symptoms of PD
Time frame: 1 year
To use neuroimaging biomarkers (MEG and FDG-PET) to examine localized effects of NBM stimulation
Time frame: with NBM turned on and off, 22 and 30 weeks after surgery respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 21708219Bentley P, Driver J, Dolan RJ. Cholinergic modulation of cognition: insights from human pharmacological functional neuroimaging. Prog Neurobiol. 2011 Sep 1;94(4):360-88. doi: 10.1016/j.pneurobio.2011.06.002. Epub 2011 Jun 17.
- Background: PubMed 19386543Bosboom JL, Stoffers D, Stam CJ, Berendse HW, Wolters ECh. Cholinergic modulation of MEG resting-state oscillatory activity in Parkinson's disease related dementia. Clin Neurophysiol. 2009 May;120(5):910-5. doi: 10.1016/j.clinph.2009.03.004. Epub 2009 Apr 21.
- Background: PubMed 26459361Combs HL, Folley BS, Berry DT, Segerstrom SC, Han DY, Anderson-Mooney AJ, Walls BD, van Horne C. Cognition and Depression Following Deep Brain Stimulation of the Subthalamic Nucleus and Globus Pallidus Pars Internus in Parkinson's Disease: A Meta-Analysis. Neuropsychol Rev. 2015 Dec;25(4):439-54. doi: 10.1007/s11065-015-9302-0. Epub 2015 Oct 12.
- Background: PubMed 23411693Di Santo SG, Prinelli F, Adorni F, Caltagirone C, Musicco M. A meta-analysis of the efficacy of donepezil, rivastigmine, galantamine, and memantine in relation to severity of Alzheimer's disease. J Alzheimers Dis. 2013;35(2):349-61. doi: 10.3233/JAD-122140.
- Background: PubMed 18098298Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
- Background: PubMed 27670207Fasano A, Appel-Cresswell S, Jog M, Zurowkski M, Duff-Canning S, Cohn M, Picillo M, Honey CR, Panisset M, Munhoz RP. Medical Management of Parkinson's Disease after Initiation of Deep Brain Stimulation. Can J Neurol Sci. 2016 Sep;43(5):626-34. doi: 10.1017/cjn.2016.274.
- Background: PubMed 19506141Freund HJ, Kuhn J, Lenartz D, Mai JK, Schnell T, Klosterkoetter J, Sturm V. Cognitive functions in a patient with Parkinson-dementia syndrome undergoing deep brain stimulation. Arch Neurol. 2009 Jun;66(6):781-5. doi: 10.1001/archneurol.2009.102.
- Background: PubMed 25888551Gratwicke J, Jahanshahi M, Foltynie T. Parkinson's disease dementia: a neural networks perspective. Brain. 2015 Jun;138(Pt 6):1454-76. doi: 10.1093/brain/awv104. Epub 2015 Apr 16.
- Background: PubMed 24798585Kuhn J, Hardenacke K, Lenartz D, Gruendler T, Ullsperger M, Bartsch C, Mai JK, Zilles K, Bauer A, Matusch A, Schulz RJ, Noreik M, Buhrle CP, Maintz D, Woopen C, Haussermann P, Hellmich M, Klosterkotter J, Wiltfang J, Maarouf M, Freund HJ, Sturm V. Deep brain stimulation of the nucleus basalis of Meynert in Alzheimer's dementia. Mol Psychiatry. 2015 Mar;20(3):353-60. doi: 10.1038/mp.2014.32. Epub 2014 May 6.
- Background: PubMed 11188973Kumar R, Lang AE, Rodriguez-Oroz MC, Lozano AM, Limousin P, Pollak P, Benabid AL, Guridi J, Ramos E, van der Linden C, Vandewalle A, Caemaert J, Lannoo E, van den Abbeele D, Vingerhoets G, Wolters M, Obeso JA. Deep brain stimulation of the globus pallidus pars interna in advanced Parkinson's disease. Neurology. 2000;55(12 Suppl 6):S34-9.
- Background: PubMed 25633602Liu AK, Chang RC, Pearce RK, Gentleman SM. Nucleus basalis of Meynert revisited: anatomy, history and differential involvement in Alzheimer's and Parkinson's disease. Acta Neuropathol. 2015 Apr;129(4):527-40. doi: 10.1007/s00401-015-1392-5. Epub 2015 Jan 30.
- Background: PubMed 8731052McGaughy J, Kaiser T, Sarter M. Behavioral vigilance following infusions of 192 IgG-saporin into the basal forebrain: selectivity of the behavioral impairment and relation to cortical AChE-positive fiber density. Behav Neurosci. 1996 Apr;110(2):247-65. doi: 10.1037//0735-7044.110.2.247.
- 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.
Alfonso Fasano, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US) in people with Parkinson Disease and Memory Disorders, run by University of Toronto at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cognition after GPi/NBM DBS (time frame: at baseline and 6, 14, 22, 30 and 52 weeks post surgery). The study lists 3 primary outcomes in all. 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 NCT04571112, which also lists 22 linked publications.
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 2 Nov 2022.