MOVEMENT DISORDERS RESEARCH

FA-COMS (18-1641)  

• Investigator: Trevor Hawkins, MD 
• Purpose: to learn more about Friedreich ataxia (FRDA) progression and to measure clinical and biochemical changes over time.
• Timeline: annual visits
• ClinicalTrials.gov Identifier: NCT03090789
• Key Eligibility Criteria: age 18+ years old, diagnosis: Friedreich ataxia (FRDA).
  

Seelos (22-1127)

•  Investigator: Trevor Hawkins, MD
• Purpose: to determine the safety and efficacy of two different weekly doses of the study drug on your SCA symptoms and whether the study drug can prevent the disease symptoms from progressing further.
• Treatment: SLS-005 (50% chance) or placebo (50% chance).
• Timeline: 8 in-person visits over approximately 56 weeks.
• ClinicalTrials.gov Identifier: NCT05490563
• Key Eligibility Criteria: age: 18-75 years old, diagnosis: Spinocerebellar Ataxia type 3 (SCA3).
  

Dystonia Coalition Projects-3 (20-0290)  

• Investigator: Jeanne Feuerstein, MD 
• Purpose: this research includes four related projects each having different but overlapping goals: (1) learn about how dystonia may progress over time and what causes dystonia (Natural History project), (2) develop tools to measure the severity of symptoms objectively (Objective Measures project), (3) create a collection of blood samples for analysis (Biobank project), and (4) develop an app to monitor symptom severity (optional Patient-Centered Outcomes project).
• Website: Dystonia Coalition 
• Key Eligibility Criteria: age 18+ years old, diagnosis: any isolated focal, segmental, multifocal, generalized, or hemi-dystonia, Patient-Centered Outcomes project: receiving Botulinum neurotoxin (BoNT) treatment.
  

Cytokine Observational Study (18-1356)  

• Investigator: Maureen Leehey, MD, FAAN  
• Purpose: to learn more about the level of inflammatory and other markers in the blood of patients with PD, ET, and healthy volunteers.
• Timeline: one time blood draw.
• Key Eligibility Criteria: have NOT been diagnosed with  Parkinson’s disease (PD) or essential tremor (ET), age: 60-75 years old.

ELATE (22-0016) 

• Investigator: Jeanne Feuerstein, MD
• Purpose: to see if the investigational medicine is safe and helps to reduce upper limb essential tremor.
• Treatment: investigational medicine (50% chance) or placebo (50% chance).
• Timeline: 12 in-person visits over 38 weeks.
• ClinicalTrials.gov Identifier: NCT05216250
  
• Key Eligibility Criteria: age: 18-80 years old, diagnosis: Essential Tremor (ET) for at least 1 year.
  

Cytokine Observational Study (18-1356)  

• Investigator: Maureen Leehey, MD, FAAN  
• Purpose: to learn more about the level of inflammatory and other markers in the blood of patients with PD, ET, and healthy volunteers.
• Timeline: one time blood draw.
• Key Eligibility Criteria: have NOT been diagnosed with  Parkinson’s disease (PD) or essential tremor (ET), age: 60-75 years old.

Michael J. Fox Foundation PPMI 2.0 (20-1204) 

• Investigator: Michelle Fullard, MD, MSCE  
• Purpose: to continue to obtain information from people with and without Parkinson’s disease (PD) so that researchers may better understand how PD progresses, in order to inform better treatments.
• Timeline: 2 visits annually for up to 7 years.
• ClinicalTrials.gov Identifier: NCT04477785 
• Key Eligibility Criteria: have NOT been diagnosed with PD, do NOT have a first degree relative with PD and age: 30+ years old OR have NOT been diagnosed with PD, have a first degree relative with PD and age: 60+ years old.
  

Music Therapy Clinical Trial (16-2308) 

• Investigator: Isabelle Buard, PhD 
• Purpose: to learn more about the brain function related to fine motor skills in individuals with Huntington’s disease (HD).
• Timeline: 3-4 study visits over the course of 7 weeks and 3 Neurologic Music Therapy sessions per week for 5 weeks.
• Intervention: Neurologic Music Therapy (can be done at the office of a music therapist, virtually, or in home depending on location).
• ClinicalTrials.gov Identifier: NCT03049033  
• Key Eligibility Criteria: age 30-85 years old, diagnosis: HD, have some difficulties with fine motor skills (such as buttoning, cutting your food, or typing on a keyboard).
  

Brain Imaging Research Study for Multiple System Atrophy-Parkinsonian subtype (MSA-P) (22-1462)

•  Investigator: Drew Kern, MD, MS
• Purpose: to learn more about whether a new magnetic resonance imaging (MRI) method may reveal differences between patients with the Parkinsonian Type of Multiple System Atrophy (MSA-P) and patients with Parkinson’s Disease (PD).
• Assessments: clinical exam and MRI scan.
• Timeline: 1 visit at University of Colorado Hospital, about 30 minutes.
• Key Eligibility Criteria: age: 40-80 years old, diagnosis: meets diagnostic criteria for probable MSA-P diagnosis, as defined by the American Academy of Neurology and National Institute of Health MSA diagnosis guidelines.
  

BlueRock PD Diary (22-1234)

•  Investigator: Alexander Baumgartner, MD
• Purpose: to study the impact of frequency of assessments on your changes and variability over time, reliability, and compliance for  a Parkinson’s disease diary, a 24-hour diary pertaining to your PD symptoms. This study is also intended to characterize the stability of your disease status, motor function, quality of life, and use of medications, without making any specific change to the treatment(s) selected by your doctor as a standard of care.
• Timeline: 7 in-person visits over 24 months.
• ClinicalTrials.gov Identifier: NCT05363046
• Key Eligibility Criteria: age: 39-70 years old, diagnosis: Parkinson’s Disease for 3-18 years, symptoms not adequately controlled with medications.
  

CereGate (21-5060)

• Investigator:  Drew Kern, MD, MS 
• Purpose: to find out if CereGate therapy reduces freezing of gait in participants with Parkinson’s disease with a pre-existing Gevia™ implanted deep brain stimulation (DBS) system..
• Treatment: your existing Gevia DBS system is programmed with an additional stimulation program for you to use when walking.  You continue to use your existing DBS program and existing medications. There are no new medications, surgeries or invasive procedures.
• Timeline: 5 in person visits over approximately 100 days.
• Key Eligibility Criteria: age: 21-75 years old, diagnosis: PD, currently have implanted Gevia™ DBS system, currently being treated with PD medications, currently have freezing of gait.

ExCITES-PD (22-1685)

• Investigator: Amy Amara, MD, PhD
• Purpose: to examine the impact of exercise on sleep and cognition in Parkinson’s Disease.
• Procedures: 12-24 weeks of exercise rehabilitation, testing such as brain scans, sleep studies and questionnaires.
• Timeline: 33 total weeks in study.
• Study flyer: click here 
• Key Eligibility Criteria:
  • Parkinson’s Disease (PD):
    • Age: 45 or older
    • Diagnosis: Parkinson’s Disease
    • No contraindications to exercise
  • Study Partner:
    • Age: 18 or older
    • Spends at least 10 or more hours per week with the PD subject

LUMA (22-0285)

• Investigator: Emily Forbes, DO
• Purpose: to look at whether the study drug (BIIB122) works in people with early-stage Parkinson’s disease, how safe it is in terms of medical problems known as “side effects”, and how the body handles taking it  (tolerability).
• Treatment: BIIB122 (50% chance) or placebo (50% chance).
• Timeline: 20 in-person visits during a period of up to 152 weeks.
• ClinicalTrials.gov Identifier: NCT05348785 
• Key Eligibility Criteria: age: 30-80 years old, diagnosis: Parkinson’s disease (diagnosis received within the past 2 years and at least 30 years old at time of diagnosis), never treated with PD medications OR treated with PD medications for less than 1 year.
  

Michael J. Fox Foundation PPMI 2.0 (20-1204) 

• Investigator: Michelle Fullard, MD, MSCE  
• Purpose: to continue to obtain information from people with and without Parkinson’s disease (PD) so that researchers may better understand how PD progresses, in order to inform better treatments.
• Timeline: 2 visits annually for up to 7 years.
• ClinicalTrials.gov Identifier: NCT04477785
• Key Eligibility Criteria: age 30+ years old, diagnosis: PD for ≤ 2 years, NOT currently being treated with PD medications or expected to require PD medications within 6 months.

Music Therapy Clinical Trial (16-2308) 

• Investigator: Isabelle Buard, PhD  
• Purpose: to learn more about the brain function related to fine motor skills in individuals with Parkinson’s disease (PD).
• Timeline: 3-4 study visits over the course of 7 weeks and 3 sessions per week for 5 weeks for either music therapy intervention, or occupational therapy (OT) intervention, or no intervention (location options available for interventions).
• Intervention: (1) musical intervention group A, (2) musical intervention group B, (3) standard of care OT, or (4) a waitlist group for 5 weeks.
• ClinicalTrials.gov Identifier: NCT03049033  
• Key Eligibility Criteria: age 45-85 years old, diagnosis: PD, have some difficulties with fine motor skills (such as buttoning, cutting your food, or typing on a keyboard).
  

PD GENEration: Mapping the Future of Parkinson’s Disease

•  Investigator: Jeanne Feuerstein, MD
• Purpose: a Parkinson’s Foundation initiative to help scientists advance their understanding of PD by offering genetic testing and genetic counseling at no cost for people with Parkinson’s Disease (PD).
• Assessment: one-time, home-delivered genetic testing kit.
• Study flyer: click here
• ClinicalTrials.gov Identifier: NCT04994015
• Key Eligibility Criteria: age: 18 and older, diagnosis: meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
  

SPARX3 (20-1854) 

• Investigator: Cory Christiansen, PT, PhD 
• Purpose: to learn more about the effects of aerobic exercise on people with Parkinson’s disease (PD) who have not yet started medication for their PD.
• Intervention: moderate to high intensity exercise on a treadmill
• Timeline: exercise 4x/week with periodic study visits for 24 months.
• ClinicalTrials.gov Identifier: NCT04284436 
• Key Eligibility Criteria: age 40-80 years old, diagnosis: PD ≤ 3 years, NOT currently being treated with PD medications or expected to require PD medications within 6 months.
  

Sleep Research Study (22-1244)

•  Investigator: Jeanne Feuerstein, MD
• Purpose: to learn more about abnormal sleep in Parkinson’s and Post-Traumatic Stress Disorder (PTSD).
• Timeline: 1 in-person study visit to the Anschutz campus and 7 days of wearing a sleep and motion monitor.
• Study flyer: click here
• Key Eligibility Criteria: age: 35-80 years old, diagnosis: Post-Traumatic Stress Disorder (PTSD) OR Parkinsonism, diagnosis: REM sleep behavior disorder (i.e., acting out dreams in your sleep).
  

Swallow Strength Study

• Investigator: Elizabeth Cuadrado, MS
• Purpose: a new study is looking at a device that would strengthen the muscles of your mouth to make eating and drinking easier for individuals with Parkinson’s Disease.
• Study flyer: https://www.ucdenver.edu/docs/librariesprovider61/clinical-research-pdfs/swallow-strenght-19-1850-cosd-flier-without-tabs-8-19-2022.pdf
• For more information, please call 303-724-8335 or email (preferred) quinlyn.axelson@cuanschutz.edu.
  

Trial of Parkinson’s and Zoledronic Acid (TOPAZ)

•  Investigator: Michelle Fullard, MD, MSCE
• Purpose: to learn if a medicine called Zoledronic Acid (ZA) can reduce fractures and deaths in people with Parkinson's Disease or parkinsonism.
• Intervention: one-time dose of the study treatment (either ZA or a placebo).
• Timeline: 1 in-person exam with a nurse at home and a study check-in (by email, mail, or phone) every 4 months to ask if you have any fractures for 2-5 years.
• Study flyer: click here
• ClinicalTrials.gov Identifier: NCT03924414
• Key Eligibility Criteria: age: 60 years or older, diagnosis: Parkinson’s Disease (PD) or parkinsonism, have not had a hip fracture.