Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05968703
Other study ID # 70608
Secondary ID UG3NS128150
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date August 2027

Study information

Verified date February 2024
Source Stanford University
Contact Study Coordinator
Phone 650-723-6709
Email bronte-stewart-lab@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 2027
Est. primary completion date August 2027
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Device:
Combined STN+NBM DBS
This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)

Locations

Country Name City State
United States Stanford Neuroscience Health Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Helen M. Bronte-Stewart National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From baseline to 1 year into treatment
Primary 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. From baseline to 1 year into treatment
Secondary Percent Time Freezing Duration of freezing episodes during SIP will be measured using IMUs and force plates using a validated offline algorithm. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary Tapping Speed The interstrike-interval of alternating tapping will be measured using an engineered piano keyboard. A higher interstrike-interval indicates slower tapping From baseline to 1 year into treatment
Secondary 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 From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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). From baseline to 1 year into treatment
Secondary Percent False Positives The percent of false positives during the SAT. From baseline to 1 year into treatment
Secondary Percent Misses The percent of misses of total trials during the SAT From baseline to 1 year into treatment
Secondary Average + standard deviation of response time The average and standard deviation of the response time during the SAT. From baseline to 1 year into treatment
Secondary Goal-directed focus of attention Hit rate during the first minute in the no- distractor condition for the CTET. From baseline to 1 year into treatment
Secondary Sustained attention Hit rate change slope in no-distractor condition for the CTET. From baseline to 1 year into treatment
Secondary Distractibility Hit rate difference between no-distractor and distractor conditions for the CTET. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary Trails A The time it takes to complete the task and errors. From baseline to 1 year into treatment
Secondary Trails B The time it takes to complete the task and errors. From baseline to 1 year into treatment
Secondary Symbol Digit Modalities (SDMT) Oral and Written The summation of the number of correct substitutions within the 90 second interval. From baseline to 1 year into treatment
Secondary visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Percentile of performance on visual puzzles for participant's demographic. From baseline to 1 year into treatment
Secondary Judgement of Line Orientation Percentile of performance on judgement of line orientation for participant's demographic. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
Secondary 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. From baseline to 1 year into treatment
See also
  Status Clinical Trial Phase
Completed NCT02915848 - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting NCT03648905 - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated NCT02688465 - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). Phase 4
Completed NCT05040048 - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting NCT04006210 - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations Phase 3
Completed NCT02562768 - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease Phase 1
Completed NCT00105508 - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia Phase 3
Completed NCT00105521 - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia Phase 3
Recruiting NCT06002581 - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease N/A
Completed NCT02236260 - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation N/A
Completed NCT00529724 - Body Weight Gain, Parkinson, Subthalamic Stimulation Phase 2
Active, not recruiting NCT05699460 - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed NCT03703570 - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations Phase 2
Completed NCT03462680 - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures N/A
Completed NCT02837172 - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting NCT04046276 - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease N/A
Recruiting NCT02952391 - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol N/A
Active, not recruiting NCT02937324 - The CloudUPDRS Smartphone Software in Parkinson's Study. N/A
Completed NCT02874274 - Vaccination Uptake (VAX) in PD N/A
Terminated NCT02924194 - Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease N/A