Parkinson DiseaseNCT05320523
Simultaneous DBS of the GPi and the NBM in Patients With Parkinson's Disease and Mild Cognitive Impairment
A study testing Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., GPi stimulation and NBM stimulation in people with Parkinson Disease and Mild Cognitive Impairment, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction, respectively, in patients with moderate to advanced Parkinson's disease having mild… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., GPi stimulation and NBM stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2021to Jan 2024
- 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
- Age at the time of enrollment: 50 - 75 years.
- Diagnosis of idiopathic PD according to Movement Disorders Society (MDS) criteria (Albanese et al., 2017).
- Mild cognitive impairment (MCI) related to Parkinson's disease according to MDS criteria. (Livtan et al. 2012).
- Duration of bilateral idiopathic PD: ≥ 5 years of motor symptoms.
- Modified Hoehn and Yahr stage ≥ 2 on off medication state.
- UPDRS subset III (motor) ≥ 30 points on off medication state.
Show all 10Show fewer
- Levodopa must improve PD symptoms by ≥ 30% in a levodopa challenge test, as measured by UPDRS subset III score.
- Presence of motor complications related to Parkinson's disease.
- Be willing and able to comply with all visits and study related procedures
- Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed.
Who cannot join
- Alcohol or drug abuse.
- Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
- Contraindications for deep brain stimulation (DBS) surgery.
- Heart failure, heart disease or any condition that contraindicates surgical procedures.
- Pacemaker or other active implanted stimulators.
- Clearly established Parkinson's disease dementia according to Movement Disorders Criteria.
- Participation in another drug, device, or biologics trial concurrently.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo General Hospital
São Paulo, 05403000
Rubens G Cury, MD, PhD, +551126617877, rubens_cury@usp.br
Ana Paula S Bertholo, MD, +5511998691919, anapaulabertolo@hotmail.com
About this study
Official title: Simultaneous Deep Brain Stimulation of the Globus Pallidus Internus and the Nucleus Basalis of Meynert in Patients With Parkinson's Disease and Mild Cognitive Impairment
Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction, respectively, in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
Read the detailed description
This study aims to provide a proof of safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
GPi stimulation with high-frequency ameliorates the cardinal motor symptoms and motor complications in Parkinson's disease patients, and this present study also wants to determine if additional NBM stimulation, with low-frequency stimulation, improves or slows progression of cognitive decline in patients with moderate to advanced Parkinson's disease having mild cognitive impairment, and to evaluate the effect of NBM stimulation on gait and balance impairment.
Study Design: Prospective single center Phase 1 study with double-blind randomized delayed activation of basal nucleus of Meynert neurostimulation (staggered onset design).
Planned Number of Subjects: 10 patients.
Planned Number of Sites / Countries: Single center in Brazil.
Study schedule:
- Presurgical baseline evaluation (motor on and off medication state; cognitive testing in best motor on state).
- DBS Implant Procedure.
- Postsurgical baseline evaluation (motor off state; cognitive testing in best motor on state) at 3±1 weeks after surgery and activation of globus pallidus internus neurostimulation using individualized stimulation parameters after a standard monopolar review.
- Regular adjustments of the GPi stimulation parameters aiming at the best motor improvement.
- Visit 1 (16 weeks after activation of GPi neurostimulation): motor off medication + GPi stimulation state, cognitive testing in on medication + GPi stimulation state. Randomization and blinded activation of NBM neurostimulation according to a 1:1 scheme.
- Visit 2 (16 weeks after randomization): motor off and on medication + stimulation state (GPi stimulation ± NBM stimulation); cognitive testing in motor on medication + stimulation state (GPi stimulation ± NBM stimulation). Activation of NBM neurostimulation in all patients.
- Visit 3 (16 weeks after activation of NBM stimulation in all patients): motor off and on medication + GPi and NBM stimulation state; cognitive testing in motor on medication + GPi and NBM stimulation state.
- Annual follow-up visit for up to 5 years after activation of NBM stimulation.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., GPi stimulation, NBM stimulation, Sham stimulation
- Keywords
- Parkinson's disease, Mild cognitive impairment, Globus Pallidus internus (GPi) Stimulation, Nucleus basalis of Meynert (NBM) Stimulation, Deep Brain Stimulation (DBS)
- 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.
Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM.Device
Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM, at the same trajectory.
GPi stimulationDevice
Bilateral high-frequency neurostimulation of the GPi using a Vercise neurostimulation system
NBM stimulationDevice
Bilateral low-frequency neurostimulation of the NBM using a Vercise neurostimulation system
Sham stimulationDevice
Ineffective neurostimulation by setting 0mA output at the Vercise neurostimulation system
| Study group | Role | What they receive |
|---|---|---|
| GPi stimulation + NBM stimulation | Active comparator | effective neurostimulation of the Nucleus basalis Meynert combined with globus pallidus internus (GPi) stimulation using Vercise deep brain stimulation Receives: Device: Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM.; Device: GPi stimulation; Device: NBM stimulation |
| GPi stimulation + sham stimulation | Sham comparator | ineffective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation Receives: Device: Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM.; Device: GPi stimulation; Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease with mild cognitive impairment as determined by reported adverse events.
Safety of combined bilateral GPi and NBM stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment as determined by reported adverse events.
Measured: 36 weeks
Secondary outcomes (27)
Change in Parkinson's Disease - Cognitive Rating Scale (PD-CRS).
This scale can range from 0 to 134, and higher scores mean a better outcome.
Measured: 36 weeks
Change in Mattis Dementia Rating Scale.
This scale can range from 0 to 144, and higher scores mean a better outcome.
Measured: 36 weeks
Change in Verbal Fluency Battery.
FAS and animals
Measured: 36 weeks
Change in Trail Making Task.
Trail Making Task Part A + B.
Measured: 36 weeks
Change in Stroop Test.
Stroop Test (Victoria Version).
Measured: 36 weeks
Change in Symbol Digit Modalities Test.
Digit symbol coding - WAIS.
Measured: 36 weeks
Change in Parkinson's Disease Questionnaire for quality of life (PDQ-39).
This questionnaire can range from 0 to 100%, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Questionnaire of the EuroQol-group (EQ-5D-5L).
This questionnaire can range from 0 to 25, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section I (UPDRS I).
This scale can range from 0 to 52, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section II (UPDRS II).
This scale can range from 0 to 52, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section III (UPDRS III).
This scale can range from 0 to 132, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section IV (UPDRS IV).
This scale can range from 0 to 24, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess step speed.
Measured: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess number of steps per minute.
Measured: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess distance between heels.
Measured: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess balance.
Measured: 36 weeks
Change in objective assessment of gait measured by Time Up and Go - Test 3 meters (TUG test 3M).
Measured: 36 weeks
Change in objective assessment of gait measured by Time Up and Go dual task - Test 3 meters (TUG dual task - test 3M).
Measured: 36 weeks
Change in objective assessment of gait measured by freezing of gait score (FOG score).
Measured: 36 weeks
Change in New Freezing of Gait Questionnaire (N-FOG).
This questionnaire can range from 0 to 28, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Falls Efficacy Scale International (FES-I).
This questionnaire can range from 0 to 64, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale).
This scale can range from 0 to 100%, and higher scores mean a better outcome.
Measured: 36 weeks
Change in Beck Depression Inventory (BDI).
This inventory can range from 0 to 63, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Beck Anxiety Inventory (BAI).
This inventory can range from 0 to 63, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Starkstein Apathy Scale.
This scale can range from 0 to 42, and higher scores mean a worse outcome.
Measured: 36 weeks
Change in Neuropsychiatric Inventory (NPI).
Measured: 36 weeks
Change in Ardouin Scale of Behavior in Parkinson's Disease.
This scale can range from 0 to 84, and higher scores mean a worse outcome.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start20 Jul 2021
- Primary completionAug 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Sao Paulo General HospitalThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320523
- Sponsor's protocol ID
- 38865720.1.0000.0068
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gratwicke J, Zrinzo L, Kahan J, Peters A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Limousin P, Hariz M, Jahanshahi M, Foltynie T. Bilateral Deep Brain Stimulation of the Nucleus Basalis of Meynert for Parkinson Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):169-178. doi: 10.1001/jamaneurol.2017.3762.
PubMed 29255885Nombela C, Lozano A, Villanueva C, Barcia JA. Simultaneous Stimulation of the Globus Pallidus Interna and the Nucleus Basalis of Meynert in the Parkinson-Dementia Syndrome. Dement Geriatr Cogn Disord. 2019;47(1-2):19-28. doi: 10.1159/000493094. Epub 2019 Jan 10.
PubMed 30630160Sankar T, Lipsman N, Lozano AM. Deep brain stimulation for disorders of memory and cognition. Neurotherapeutics. 2014 Jul;11(3):527-34. doi: 10.1007/s13311-014-0275-0.
PubMed 24777384Kuhn 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 24798585Freund 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 19506141Wilson J, Yarnall AJ, Craig CE, Galna B, Lord S, Morris R, Lawson RA, Alcock L, Duncan GW, Khoo TK, O'Brien JT, Burn DJ, Taylor JP, Ray NJ, Rochester L. Cholinergic Basal Forebrain Volumes Predict Gait Decline in Parkinson's Disease. Mov Disord. 2021 Mar;36(3):611-621. doi: 10.1002/mds.28453. Epub 2020 Dec 31.
PubMed 33382126Muller ML, Bohnen NI. Cholinergic dysfunction in Parkinson's disease. Curr Neurol Neurosci Rep. 2013 Sep;13(9):377. doi: 10.1007/s11910-013-0377-9.
PubMed 23943367Gratwicke J, Zrinzo L, Kahan J, Peters A, Brechany U, McNichol A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Crutch SJ, Taylor JP, McKeith I, Rochester L, Schott JM, Limousin P, Burn D, Rossor MN, Hariz M, Jahanshahi M, Foltynie T. Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial. Brain Stimul. 2020 Jul-Aug;13(4):1031-1039. doi: 10.1016/j.brs.2020.04.010. Epub 2020 Apr 22.
PubMed 32334074Dalrymple WA, Huss DS, Blair J, Flanigan JL, Patrie J, Sperling SA, Shah BB, Harrison MB, Druzgal TJ, Barrett MJ. Cholinergic nucleus 4 atrophy and gait impairment in Parkinson's disease. J Neurol. 2021 Jan;268(1):95-101. doi: 10.1007/s00415-020-10111-2. Epub 2020 Jul 28.
PubMed 32725313Koulousakis P, Andrade P, Visser-Vandewalle V, Sesia T. The Nucleus Basalis of Meynert and Its Role in Deep Brain Stimulation for Cognitive Disorders: A Historical Perspective. J Alzheimers Dis. 2019;69(4):905-919. doi: 10.3233/JAD-180133.
PubMed 31104014
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Deep Brain Stimulation of the Globus Pallidus Internus and the Nucleus Basalis of Meynert in Patients With Parkinson's Disease and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05320523
- Acronym / sponsor ID
- 38865720.1.0000.0068
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Keywords
- Parkinson's disease, Mild cognitive impairment, Globus Pallidus internus (GPi) Stimulation, Nucleus basalis of Meynert (NBM) Stimulation, Deep Brain Stimulation (DBS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 11 Apr 2022 (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.
Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction, respectively, in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
Detailed description
This study aims to provide a proof of safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
GPi stimulation with high-frequency ameliorates the cardinal motor symptoms and motor complications in Parkinson's disease patients, and this present study also wants to determine if additional NBM stimulation, with low-frequency stimulation, improves or slows progression of cognitive decline in patients with moderate to advanced Parkinson's disease having mild cognitive impairment, and to evaluate the effect of NBM stimulation on gait and balance impairment.
Study Design: Prospective single center Phase 1 study with double-blind randomized delayed activation of basal nucleus of Meynert neurostimulation (staggered onset design).
Planned Number of Subjects: 10 patients.
Planned Number of Sites / Countries: Single center in Brazil.
Study schedule:
- Presurgical baseline evaluation (motor on and off medication state; cognitive testing in best motor on state).
- DBS Implant Procedure.
- Postsurgical baseline evaluation (motor off state; cognitive testing in best motor on state) at 3±1 weeks after surgery and activation of globus pallidus internus neurostimulation using individualized stimulation parameters after a standard monopolar review.
- Regular adjustments of the GPi stimulation parameters aiming at the best motor improvement.
- Visit 1 (16 weeks after activation of GPi neurostimulation): motor off medication + GPi stimulation state, cognitive testing in on medication + GPi stimulation state. Randomization and blinded activation of NBM neurostimulation according to a 1:1 scheme.
- Visit 2 (16 weeks after randomization): motor off and on medication + stimulation state (GPi stimulation ± NBM stimulation); cognitive testing in motor on medication + stimulation state (GPi stimulation ± NBM stimulation). Activation of NBM neurostimulation in all patients.
- Visit 3 (16 weeks after activation of NBM stimulation in all patients): motor off and on medication + GPi and NBM stimulation state; cognitive testing in motor on medication + GPi and NBM stimulation state.
- Annual follow-up visit for up to 5 years after activation of NBM stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPi stimulation + NBM stimulation | Active comparator | Device: Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., Device: GPi stimulation, Device: NBM stimulationeffective neurostimulation of the Nucleus basalis Meynert combined with globus pallidus internus (GPi) stimulation using Vercise deep brain stimulation |
| GPi stimulation + sham stimulation | Sham comparator | Device: Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., Device: GPi stimulation, Device: Sham stimulationineffective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age at the time of enrollment: 50 - 75 years.
- Diagnosis of idiopathic PD according to Movement Disorders Society (MDS) criteria (Albanese et al., 2017).
- Mild cognitive impairment (MCI) related to Parkinson's disease according to MDS criteria. (Livtan et al. 2012).
- Duration of bilateral idiopathic PD: ≥ 5 years of motor symptoms.
- Modified Hoehn and Yahr stage ≥ 2 on off medication state.
Key exclusion criteria (7 listed)
- Alcohol or drug abuse.
- Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
- Contraindications for deep brain stimulation (DBS) surgery.
- Heart failure, heart disease or any condition that contraindicates surgical procedures.
- Pacemaker or other active implanted stimulators.
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 |
|---|---|---|
| Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM.Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM, at the same trajectory. | Device | GPi stimulation + NBM stimulation, GPi stimulation + sham stimulation |
| GPi stimulationBilateral high-frequency neurostimulation of the GPi using a Vercise neurostimulation system | Device | GPi stimulation + NBM stimulation, GPi stimulation + sham stimulation |
| NBM stimulationBilateral low-frequency neurostimulation of the NBM using a Vercise neurostimulation system | Device | GPi stimulation + NBM stimulation |
| Sham stimulationIneffective neurostimulation by setting 0mA output at the Vercise neurostimulation system | Device | GPi stimulation + sham stimulation |
Primary outcome
Safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease with mild cognitive impairment as determined by reported adverse events.
Time frame: 36 weeks
Safety of combined bilateral GPi and NBM stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment as determined by reported adverse events.
27 secondary outcomes
Change in Parkinson's Disease - Cognitive Rating Scale (PD-CRS).
Time frame: 36 weeks
Change in Mattis Dementia Rating Scale.
Time frame: 36 weeks
Change in Verbal Fluency Battery.
Time frame: 36 weeks
Change in Trail Making Task.
Time frame: 36 weeks
Change in Stroop Test.
Time frame: 36 weeks
Change in Symbol Digit Modalities Test.
Time frame: 36 weeks
Change in Parkinson's Disease Questionnaire for quality of life (PDQ-39).
Time frame: 36 weeks
Change in Questionnaire of the EuroQol-group (EQ-5D-5L).
Time frame: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section I (UPDRS I).
Time frame: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section II (UPDRS II).
Time frame: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section III (UPDRS III).
Time frame: 36 weeks
Change in Unified Parkinson's Disease Rating Scale section IV (UPDRS IV).
Time frame: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess step speed.
Time frame: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess number of steps per minute.
Time frame: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess distance between heels.
Time frame: 36 weeks
Change in objective assessment of gait measured by a sensor (MobilityLab) that assess balance.
Time frame: 36 weeks
Change in objective assessment of gait measured by Time Up and Go - Test 3 meters (TUG test 3M).
Time frame: 36 weeks
Change in objective assessment of gait measured by Time Up and Go dual task - Test 3 meters (TUG dual task - test 3M).
Time frame: 36 weeks
Change in objective assessment of gait measured by freezing of gait score (FOG score).
Time frame: 36 weeks
Change in New Freezing of Gait Questionnaire (N-FOG).
Time frame: 36 weeks
Change in Falls Efficacy Scale International (FES-I).
Time frame: 36 weeks
Change in Activities-Specific Balance Confidence Scale (ABC scale).
Time frame: 36 weeks
Change in Beck Depression Inventory (BDI).
Time frame: 36 weeks
Change in Beck Anxiety Inventory (BAI).
Time frame: 36 weeks
Change in Starkstein Apathy Scale.
Time frame: 36 weeks
Change in Neuropsychiatric Inventory (NPI).
Time frame: 36 weeks
Change in Ardouin Scale of Behavior in Parkinson's Disease.
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 29255885Gratwicke J, Zrinzo L, Kahan J, Peters A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Limousin P, Hariz M, Jahanshahi M, Foltynie T. Bilateral Deep Brain Stimulation of the Nucleus Basalis of Meynert for Parkinson Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):169-178. doi: 10.1001/jamaneurol.2017.3762.
- Results publication: PubMed 30630160Nombela C, Lozano A, Villanueva C, Barcia JA. Simultaneous Stimulation of the Globus Pallidus Interna and the Nucleus Basalis of Meynert in the Parkinson-Dementia Syndrome. Dement Geriatr Cogn Disord. 2019;47(1-2):19-28. doi: 10.1159/000493094. Epub 2019 Jan 10.
- Results publication: PubMed 24777384Sankar T, Lipsman N, Lozano AM. Deep brain stimulation for disorders of memory and cognition. Neurotherapeutics. 2014 Jul;11(3):527-34. doi: 10.1007/s13311-014-0275-0.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 33382126Wilson J, Yarnall AJ, Craig CE, Galna B, Lord S, Morris R, Lawson RA, Alcock L, Duncan GW, Khoo TK, O'Brien JT, Burn DJ, Taylor JP, Ray NJ, Rochester L. Cholinergic Basal Forebrain Volumes Predict Gait Decline in Parkinson's Disease. Mov Disord. 2021 Mar;36(3):611-621. doi: 10.1002/mds.28453. Epub 2020 Dec 31.
- Results publication: PubMed 23943367Muller ML, Bohnen NI. Cholinergic dysfunction in Parkinson's disease. Curr Neurol Neurosci Rep. 2013 Sep;13(9):377. doi: 10.1007/s11910-013-0377-9.
- Results publication: PubMed 32334074Gratwicke J, Zrinzo L, Kahan J, Peters A, Brechany U, McNichol A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Crutch SJ, Taylor JP, McKeith I, Rochester L, Schott JM, Limousin P, Burn D, Rossor MN, Hariz M, Jahanshahi M, Foltynie T. Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial. Brain Stimul. 2020 Jul-Aug;13(4):1031-1039. doi: 10.1016/j.brs.2020.04.010. Epub 2020 Apr 22.
- Results publication: PubMed 32725313Dalrymple WA, Huss DS, Blair J, Flanigan JL, Patrie J, Sperling SA, Shah BB, Harrison MB, Druzgal TJ, Barrett MJ. Cholinergic nucleus 4 atrophy and gait impairment in Parkinson's disease. J Neurol. 2021 Jan;268(1):95-101. doi: 10.1007/s00415-020-10111-2. Epub 2020 Jul 28.
- Results publication: PubMed 31104014Koulousakis P, Andrade P, Visser-Vandewalle V, Sesia T. The Nucleus Basalis of Meynert and Its Role in Deep Brain Stimulation for Cognitive Disorders: A Historical Perspective. J Alzheimers Dis. 2019;69(4):905-919. doi: 10.3233/JAD-180133.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation implantation of a Vercise neurostimulation system in GPi and NBM., GPi stimulation and NBM stimulation in people with Parkinson Disease and Mild Cognitive Impairment, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 10 inclusion and 7 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 11 Apr 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease with mild cognitive impairment as determined by reported adverse events. (time frame: 36 weeks). 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 NCT05320523, which also lists 10 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 11 Apr 2022.