Stanford Movement Disorders Center Clinical Trials

The Role of the Gut Microbiome in Parkinson’s Disease
Studies show that the gut microbiome in Parkinson’s patients is different from the gut microbiome in healthy individuals. What is not clear, however, is how these differences impact one’s risk for developing Parkinson’s Disease or how the different microbiome in Parkinson’s patients impacts disease course. Additionally, in Parkinson’s patients there is chronic systemic inflammation due to excessive immune activity, and the gut microbiome is known to impact immune functioning. Therefore, in this study we examine whether the differences in the microbiome of Parkinson’s patients are associated with increased inflammatory markers in the blood, and whether the differences in microbiome impact immune cell activation. Through this study, we hope to better understand the mechanism by which the microbiome in Parkinson’s patients may be contributing to the disease. In the future, these findings could be used to develop disease treatments that target the microbiome. We are recruiting individuals who have been diagnosed by a neurologist with Parkinson’s Disease and healthy individuals from the same house. Participation entails answering an online questionnaire and giving small amounts of blood and stool. Each participant will receive a gift card for their involvement.
PI: Bianca Palushaj, MD
Co-PI: Ami S. Bhatt, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinators: Meena Chakraborty, Erin Brooks, Gabriella Green
Contact: mchakra@stanford.edu, efbrooks@stanford.edu, gzmg1@stanford.edu

Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Purpose: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. VCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
Sponsor: Stanford University, Synergic Medical Technologies, Inc.
PI: Peter Tass, MD, PhD
Co-PI: Leila Montaser Kouhsari, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinator: Jessica Kalinova Yankulova
Contact: parkinsonsvcr@stanford.edu

Blood biomarkers study in REM sleep behavior disorder (RBD)
Purpose: studying neuroinflammation and immune protective factors in patients with RBD
PI: Emmanuel H. During, MD
Co-PI: Emmanuel Mignot, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas 
acahuas@stanford.edu 650 721 5489

Home diagnosis of REM sleep behavior disorder (RBD) using wearable sleep trackers
Purpose: developing a machine learning method to diagnose RBD in the home environment with wrist-worn actigraphy
PI: Emmanuel H. During, MD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas 
acahuas@stanford.edu 650 721 5489

U19 North American Prodromal Synucleinopathy (NAPS) consortium
Purpose: Neuroprotection trial planning in REM sleep behavior disorder (RBD)
PI: Emmanuel H. During, MD
Study status: Open, enrollment ongoing
Research Coordinator: Vincent Nguyen
vnguyen9@stanford.edu

Sodium Oxybate in Refractory REM Sleep Behavior Disorder: A Randomized Controlled Study
Purpose: This study evaluates the efficacy of sodium oxybate in individuals with and without Parkinson’s disease who act out their dreams (REM Sleep Behavior Disorder, known as “RBD”) and do not respond to usual therapies.
PI: Emmanuel H. During, MD
Co-PI: Mitchell Miglis, MD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas 
acahuas@stanford.edu 650 721 5489

Pacific Udall Center
Sponsor: NIH/NINDS Morris K. Udall Center of Excellence for Parkinson's Disease Research
PI: Tom Montine, MD, PhD
Study status: Open, Enrollment ongoing
Research coordinator: Maria-Lucia Campos
udallcenter@stanford.edu  (650) 721-5351

Healthy Brain Aging Study
Sponsor: NIH/NIA
PI:Victor Henderson, MD and Tony Wyss-Coray, PhD
Study Status: Open, enrollment ongoing
Research coordinator: Christina Wyss-Coray
ADRCstanford@stanford.edu (650) 721-2409

Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait using Neural and Kinematic Feedback (NCT04043403)
Sponsor(s): NIH/NINDS, BRAIN Initiative
Purpose: This study aims to investigate the safety and feasibility of adaptive deep brain stimulation for impaired gait and freezing of gait in Parkinson’s disease, driven by subject-specific neural or behavioral control variables, and in response to medication.
PI: Helen Bronte-Stewart, MD, MS
Study status: Open, enrollment ongoing
Research coordinator: Sudeep Aditham
sudeepa@stanford.edu (650) 723-6709

The Natural History of Synucleinopathies
PI: Mitchell Miglis, MD
Study status: Open, enrollment by invitation only
Research coordinator: Jordan Seliger
jseliger@gmail.com

Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson’s Disease Dementia (NCT03305809)
Study Status: Closed to enrollment, study ongoing
PI: Laurice Yang, MD, MHA
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu

Neural Signatures of Tremor, Bradykinesia and Freezing in the Subthalamic Region in Parkinson’s Disease and their Acute and Long-Term Modulation by Subthalamic Deep Brain Stimulation
Clinical Trials Protocol #: NCT01990313
Sponsor: Medtronic
PI: Helen Bronte Stewart, MD, MS
Study status: Closed to enrollment, study ongoing
Research coordinator: Sudeep Aditham
sudeepa@stanford.edu (650) 723-6709

Neurodegeneration and Brain Function in Aging with HIV and Parkinson's Disease
Sponsor: NIH/NINDS
Site PI: Helen Bronte-Stewart, MD, MS
Study Status: Closed to enrollment, analysis ongoing
Research coordinator: (650-723-6709)

The Stanford Parkinson's Disease Plasma Study
Clinical Trials Protocol #: NCT02968433
PI: Helen Bronte-Stewart, MD, MS
Study Status: Closed to enrollment, analysis ongoing
Research coordinator: (650-723-6709)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease (NCT03318523)
Study Status: Closed to enrollment, analysis ongoing
PI: Laurice Yang, MD, MHA

Functional Networks in Parkinson's Disease - an fMRI Activation and Functional Connectivity Study
Sponsor: NIH/NINDS
PI: Kathleen Poston, MD, MS
Study Status: Closed to enrollment, analysis ongoing
Research coordinator: Marian Shahid, MSc
mshahid@stanford.edu (650) 723-0060  

Multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant (NCT02906020)
Study Status: Closed to enrollment, analysis ongoing
PI: Kathleen Poston, MD, MS
Research Coordinator: Emma Adair
Contact: eadair@stanford.edu

Development of Multimodal Imaging Biomarkers for Cognitive Dysfunction in Parkinson's Disease
Sponsor: The Michael J. Fox Foundation for Parkinson’s disease Research
PI: Kathleen Poston, MD, MS
Study status: Enrollment closed, analysis ongoing
Research coordinator: Marian Shahid, MSc
mshahid@stanford.edu (650) 723-0060  

Structural Correlates of Cognitive and Motor Dysfunction in Parkinsonian Disorders
PI: Kathleen Poston, MD, MS
Study Status: Closed to enrollment, outcome published
Research coordinator: Marian Shahid, MSc
mshahid@stanford.edu (650) 723-0060  

A Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects With Idiopathic Parkinson’s Disease
Clinical Trials Protocol #: NCT00400634
Sponsor: Sangamo Biosciences, Inc
Site PI: Kathleen Poston, MD, MS
Study Status: Closed to enrollment, outcome published
Research coordinator: Marian Shahid, MSc
mshahid@stanford.edu (650) 723-0060