Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around
Principal Investigator
by Ann Ly, MD

Description

Summary

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

Keywords

Essential Tremor, Movement Disorders, Essential Tremor, Essential Tremor-plus, skin biopsy, Syn-One, Movement Disorders, Essential Tremor Plus

Eligibility

You can join if…

Open to people ages 50-85

  • 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.

Locations

  • University of California Irvine Health not yet accepting patients
    Irvine California 92617 United States
  • Cedars-Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • CND Clinical Research Center accepting new patients
    Scottsdale Arizona 85258 United States
  • Movement Disorders Center of Arizona accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
CND Life Sciences
ID
NCT07428447
Study Type
Observational
Participants
Expecting 300 study participants
Last Updated