What this study is
Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually. Post-mortem studies reveal Lewy body pathology in some ET patients, suggesting a subset may have prodromal PD. Current diagnostic tools (DaTscan, SYNTap) are either insufficiently sensitive for early disease, too expensive, or too invasive for routine screening. The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies.
Primary Objectives
1. Identify which ET patients have P-SYN pathology indicative of prodromal PD 2. Predict which patients are most likely to phenoconvert to PD
Study details
- Sponsor
- CND Life Sciences
- Conditions
- Essential Tremor, Movement Disorders · Essential Tremor · Essential Tremor-plus
- Enrolling
- 300 people
- Starts
- 2026-02-18
- Est. completion
- 2029-02
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 50-85 years old
- Diagnosis of ET as defined by the 2018 MDS Task force paper "1) isolated tremor syndrome of bilateral upper limb action tremor 2) at least 3 years' duration 3) with or without tremor in other locations (e.g., head, voice, or lower limbs) 4) absence of other neurological signs, such as dystonia, ataxia, or parkinsonism." OR
- Diagnosis of ET-Plus as stated by the 2018 MDS Task force paper, "Tremor with the characteristics of ET and additional neurological signs of uncertain significance such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurologic signs of unknown significance that do not suffice to make an additional syndrome classification or diagnosis. ET with tremor at rest should be classified here."
- Willing to participate in all study procedures
- Able and willing to provide written informed consent
You can't join if
- Under age 50, Over age 85
- Clinical evidence of severe peripheral vascular disease
- Clinically active coronary artery or cerebrovascular disease
- Participant is currently on anticoagulant or dual anti-platelet therapy
- Alcoholism
- Allergic reaction to local anesthesia
- History of or increased risk for impaired wound healing, scarring, or keloid formation
- Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise
- History of other neurodegenerative disorder or evidence of neurological co-pathology
- Abnormal DaTscan
- Participant is currently receiving treatment with carbidopa-levodopa for PD
- Isolated focal tremors (head, voice)
- Task-specific tremor (e.g., primary writing tremor)
- Position-specific tremors that does not otherwise meet clinical diagnostic criteria for ET
- Sudden onset and step-wise deterioration
- Prior to enrollment, receipt of an intracranial procedure intended to treat tremor or parkinsonism, including thalamic deep brain stimulation (DBS) implantation or focused ultrasound (FUS) thalamotomy. Other prior intracranial surgery is exclusionary only when, in the investigator's or Sponsor's Chief Medical Officer's judgment, it could materially affect motor assessments, diagnostic classification, participant safety, or interpretation of study outcomes.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
11 openCND Clinical Research Center
Scottsdale, Arizona, United States
- Jeannie Director of Clinical Research · Contact480-434-6446 ext. 371ClinicalResearch@cndlifesciences.com
- Padma Mahant, MD · Principal investigator
RecruitingMovement Disorders Center of Arizona
Scottsdale, Arizona, United States
- Danica Evidente · Contact480-526-5441danica@movementdisorders.us
- Virgilio Gerald H Evidente, MD · Principal investigator
RecruitingUniversity of California Irvine Health
Irvine, California, United States
- Shivani Venkateswaran · Contactshivanv1@uci.edu
- Ann Ly, MD · Principal investigator
- Niki Maki, MD · Sub-investigator
Not yet recruitingCedars-Sinai Medical Center
Los Angeles, California, United States
- Michele Lima Gregorio, PhD · Contact424-315-0021michele.gregorio@cshs.org
- Anne Tran · Contact310-423-1697anne.tran@cshs.org
- Michele Tagliati, MD · Principal investigator
Not yet recruitingNeurology One
Orlando, Florida, United States
- Jinna Santiago, RN, CRC · Contact407-706-3060 ext. 110jsantiago@n1research.org
- Victor Lameda, CRC · Contact407-706-3060 ext. 109vlameda@n1research.org
- Ramon L Rodriguez, MD, FAAN · Principal investigator
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Kim Lee, Clinical Research Coordinator · Contact913-588-0013klee9@kumc.edu
- Angela Richmond, MD · Principal investigator
- Kelly Lyons, PhD · Sub-investigator
Not yet recruitingNorton Healthcare
Louisville, Kentucky, United States
- Andrea J Gambrell, RN, BSN, CCM · Contact502-446-8544andrea.gambrell@nortonhealthcare.org
- Hannah Scully, RN · Contact502-588-0719hannah.scully@nortonhealthcare.org
- Jason Crowell, MD · Principal investigator
- Justin Phillips, MD · Sub-investigator
RecruitingQuest Research Institute
Farmington Hills, Michigan, United States
- Denise Morgott · Contact248-957-8940denise.morgott@questri.com
- Aaron Ellenbogen, DO · Principal investigator
RecruitingVeracity Neurosciences LLC
Memphis, Tennessee, United States
- Hannah Touliatos · Contact901-443-9170hannah@veracityneuroscience.com
- Mark LeDoux, MD, PhD · Principal investigator
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Jackie Harris, RMA, CTRC IV · Contact615-936-3833jacqueline.c.harris@vumc.org
- Keimora Wright, CTRC II · Contact615-322-0530keimora.wright@vumc.org
- Cherrie Yu, MD · Principal investigator
- Amanda Currie, MD · Sub-investigator
Not yet recruitingBaylor College of Medicine
Houston, Texas, United States
- Haneyeh Primary Research Coordinator · Contact713-798-5120haneyeh.amidi@bcm.edu
- Rory Research Manager · Contact713-798-5989Rory.Mahabir@bcm.edu
- Steven Bellows, MD · Principal investigator
- Karim Makhoul, MD · Sub-investigator
- Yutong Taneff, NP · Sub-investigator
Recruiting
Study team
Sponsor
CND Life Sciences
Study ID CND-106
CONTACT
Jeannie Director of Clinical Research
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.