Parkinson's DiseaseNCT05968703
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
A study testing Combined STN+NBM DBS in people with Parkinson's Disease and Mild Cognitive Impairment, run by Helen M. Bronte-Stewart at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson's Disease, Mild Cognitive Impairment
- What is being tested?
- Combined STN+NBM DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease (PD)
- Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
- Willingness to withdraw from clinical medication regimen when necessary for research visits
- Ability to provide informed consent
Who cannot join
- Dementia
- Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
- History of seizures
- Pregnant
- Requires MRI
- Unable to walk 100 feet without an assistive device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Neuroscience Health Center
Stanford, California, 94305
Study Coordinator, 650-723-6709, bronte-stewart-lab@stanford.edu
About this study
Official title: Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Being tested
- Combined STN+NBM DBS
- Keywords
- deep brain stimulation, cognition, DBS, parkinson's disease
- 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.
Combined STN+NBM DBSDevice
This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
| Study group | Role | What they receive |
|---|---|---|
| Vertical Nuclear Trajectory | Experimental | Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself. Receives: Device: Combined STN+NBM DBS |
| Lateral NBM Bundle Trajectory | Experimental | Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM Receives: Device: Combined STN+NBM DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study
Measured: From baseline to 1 year into treatment
Swing Time Coefficient of Variation
Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.
Measured: From baseline to 1 year into treatment
Secondary outcomes (28)
Percent Time Freezing
Duration of freezing episodes during SIP will be measured using IMUs and force plates using a validated offline algorithm.
Measured: From baseline to 1 year into treatment
Stride Time Coefficient of Variation
Stride time coefficient of variation will be measured using the dual force plates in the SIP task and IMUs. Stride time coefficient of variation is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping.
Measured: From baseline to 1 year into treatment
Shank Angular Velocity
Shank angular velocity will be measured from IMUs work on the participant's leg/ankle. Reductions in this value are indicative of FOG and gait impairment.
Measured: From baseline to 1 year into treatment
Tapping Speed
The interstrike-interval of alternating tapping will be measured using an engineered piano keyboard. A higher interstrike-interval indicates slower tapping
Measured: From baseline to 1 year into treatment
Tapping Rhythmicity
The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered piano keyboard. A higher coefficient of variation indicates worse rhythmicity
Measured: From baseline to 1 year into treatment
MDS-UPDRS III Score
PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132.
Measured: From baseline to 1 year into treatment
SAT Score
Each trial of the SAT will be categorized as a Hit (H), Miss (M), or False Alarm (FA). The SAT score is defined as ((H - FA) / [2× (H + FA) - (H + FA)2]), which ranges from - 1.0 (100% incorrect performance; all misses and false alarms) to +1.0 (100% correct performance; all hits and correct rejections).
Measured: From baseline to 1 year into treatment
Percent False Positives
The percent of false positives during the SAT.
Measured: From baseline to 1 year into treatment
Percent Misses
The percent of misses of total trials during the SAT
Measured: From baseline to 1 year into treatment
Average + standard deviation of response time
The average and standard deviation of the response time during the SAT.
Measured: From baseline to 1 year into treatment
Goal-directed focus of attention
Hit rate during the first minute in the no- distractor condition for the CTET.
Measured: From baseline to 1 year into treatment
Sustained attention
Hit rate change slope in no-distractor condition for the CTET.
Measured: From baseline to 1 year into treatment
Distractibility
Hit rate difference between no-distractor and distractor conditions for the CTET.
Measured: From baseline to 1 year into treatment
Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
Cognitive scale composed of 9 tasks that assesses the full range of cognitive dysfunction in PD. It is a scale of 0 to 134, with 134 being the best score.
Measured: From baseline to 1 year into treatment
Montreal Cognitive Assessment (MoCA)
Total score to assess of this rapid screening test of different cognitive domains. It is a scale of 0 to 30, with 30 being the best score.
Measured: From baseline to 1 year into treatment
Trails A
The time it takes to complete the task and errors.
Measured: From baseline to 1 year into treatment
Trails B
The time it takes to complete the task and errors.
Measured: From baseline to 1 year into treatment
Symbol Digit Modalities (SDMT) Oral and Written
The summation of the number of correct substitutions within the 90 second interval.
Measured: From baseline to 1 year into treatment
visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
Percentile of performance on visual puzzles for participant's demographic.
Measured: From baseline to 1 year into treatment
Judgement of Line Orientation
Percentile of performance on judgement of line orientation for participant's demographic.
Measured: From baseline to 1 year into treatment
Patient Health Questionnaire-9 (PHQ-9)
Total score on questionnaire regarding participant's mood the last 2 weeks. The scale ranges from 0 to 27 with a score of 27 indicating the most severe symptoms.
Measured: From baseline to 1 year into treatment
General Anxiety Disorder-7 (GAD-7)
Total score on questionnaire regarding participant's anxiety the last two weeks.The scale ranges from 0 to 21 with a score of 21 indicating the most severe symptoms.
Measured: From baseline to 1 year into treatment
MDS-UPDRS I
Total score evaluating the non-motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.
Measured: From baseline to 1 year into treatment
MDS-UPDRS II
Total score evaluating the motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.
Measured: From baseline to 1 year into treatment
MDS-UPDRS IV
Total score of motor complications experienced by the participant. It is a scale from 0 to 24 with 24 being the most severe symptoms.
Measured: From baseline to 1 year into treatment
Neuropsychiatric Inventory (NPI)
Total score for symptom severity and distress via questionnaire. It is a scale from 0 to 60 with 60 indicating worse symptoms.
Measured: From baseline to 1 year into treatment
Parkinson's Disease Questionnaire-39 (PDQ-39)
Total score for Parkinson's disease-specific health related quality over the last month across 8 quality of life dimensions assessed via questionnaire. Score ranges from 0 to 100 with 100 indicating more symptoms and problems.
Measured: From baseline to 1 year into treatment
Caregiver Burden Assessment
Total score on caregiver self-report to assess the stress-levels of family caregivers. It is a scale from 0 to 88 with higher scores indicating greater or worse burden.
Measured: From baseline to 1 year into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start8 Apr 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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
- Parallel groups
- Model description
- All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen M. Bronte-Stewart
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Helen M. Bronte-Stewart, Stanford University
- Investigators
- Helen M Bronte-Stewart, MD MSE, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968703
- Sponsor's protocol ID
- 70608
- Other IDs
- UG3NS128150, UH3NS128150
- Status last verified
- May 2025
- First submitted
- 19 Jul 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be uploaded to the Data Archive for the BRAIN Initiative (DABI).
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05968703
- Acronym / sponsor ID
- 70608
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Keywords
- deep brain stimulation, cognition, DBS, parkinson's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Helen M. Bronte-StewartUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Aug 2023 (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.
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.
| Arm | Type | Receives |
|---|---|---|
| Vertical Nuclear Trajectory | Experimental | Device: Combined STN+NBM DBSParticipants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself. |
| Lateral NBM Bundle Trajectory | Experimental | Device: Combined STN+NBM DBSParticipants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease (PD)
- Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
- Willingness to withdraw from clinical medication regimen when necessary for research visits
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Dementia
- Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
- History of seizures
- Pregnant
- Requires MRI
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 |
|---|---|---|
| Combined STN+NBM DBSThis intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) | Device | Lateral NBM Bundle Trajectory, Vertical Nuclear Trajectory |
Primary outcome
Adverse Events
Time frame: From baseline to 1 year into treatment
Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study
Swing Time Coefficient of Variation
Time frame: From baseline to 1 year into treatment
Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.
28 secondary outcomes
Percent Time Freezing
Time frame: From baseline to 1 year into treatment
Stride Time Coefficient of Variation
Time frame: From baseline to 1 year into treatment
Shank Angular Velocity
Time frame: From baseline to 1 year into treatment
Tapping Speed
Time frame: From baseline to 1 year into treatment
Tapping Rhythmicity
Time frame: From baseline to 1 year into treatment
MDS-UPDRS III Score
Time frame: From baseline to 1 year into treatment
SAT Score
Time frame: From baseline to 1 year into treatment
Percent False Positives
Time frame: From baseline to 1 year into treatment
Percent Misses
Time frame: From baseline to 1 year into treatment
Average + standard deviation of response time
Time frame: From baseline to 1 year into treatment
Goal-directed focus of attention
Time frame: From baseline to 1 year into treatment
Sustained attention
Time frame: From baseline to 1 year into treatment
Distractibility
Time frame: From baseline to 1 year into treatment
Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
Time frame: From baseline to 1 year into treatment
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to 1 year into treatment
Trails A
Time frame: From baseline to 1 year into treatment
Trails B
Time frame: From baseline to 1 year into treatment
Symbol Digit Modalities (SDMT) Oral and Written
Time frame: From baseline to 1 year into treatment
visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
Time frame: From baseline to 1 year into treatment
Judgement of Line Orientation
Time frame: From baseline to 1 year into treatment
Patient Health Questionnaire-9 (PHQ-9)
Time frame: From baseline to 1 year into treatment
General Anxiety Disorder-7 (GAD-7)
Time frame: From baseline to 1 year into treatment
MDS-UPDRS I
Time frame: From baseline to 1 year into treatment
MDS-UPDRS II
Time frame: From baseline to 1 year into treatment
MDS-UPDRS IV
Time frame: From baseline to 1 year into treatment
Neuropsychiatric Inventory (NPI)
Time frame: From baseline to 1 year into treatment
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: From baseline to 1 year into treatment
Caregiver Burden Assessment
Time frame: From baseline to 1 year into treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be uploaded to the Data Archive for the BRAIN Initiative (DABI).
Related trials for Parkinson's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Not yet recruitingPhase 2
Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
Parkinson Disease
RecruitingPhase 3
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
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.
Helen M Bronte-Stewart, MD MSE principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined STN+NBM DBS in people with Parkinson's Disease and Mild Cognitive Impairment, run by Helen M. Bronte-Stewart at 1 site in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (650-723-6709, bronte-stewart-lab@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From baseline to 1 year into treatment). The study lists 2 primary outcomes in all. 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 30 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.