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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Syn-One skin test can help find people with essential tremor who may later develop Parkinson’s disease. It checks small skin samples for a protein called phosphorylated alpha-synuclein. The study is for adults ages 50–85 with essential tremor or essential tremor-plus.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50–85 years old.
  • You have essential tremor: shaking in both arms during movement for at least 3 years, without other nerve or brain signs. Other body parts may also shake.
  • Or, you have essential tremor-plus: essential tremor with mild signs, such as balance or memory problems, that do not support another diagnosis. Shaking at rest also fits this group.
  • You are willing to take part in all study procedures.
  • You can and will give written consent to join.

Who can't join

  • You are under 50 or over 85.
  • You have severe blood vessel disease outside the heart and brain, or active disease in the blood vessels of the heart or brain.
  • You take an anticoagulant blood thinner, take two anti-platelet medicines to prevent clots, or have alcoholism.
  • You are allergic to local numbing medicine, or have a history or higher risk of poor wound healing or raised scars called keloids.
  • Your tremor likely comes from brain injury or poor blood flow, or you have another disease that damages nerve cells or another brain or nerve condition.
  • You have an abnormal DaTscan brain scan, or you take carbidopa-levodopa for Parkinson’s disease.
  • Your tremor affects only one area, such as the head or voice; happens only with a certain task; or happens only in a certain position and does not meet essential tremor rules. Sudden onset with worsening in steps also rules you out.
  • You have had a procedure inside the skull to treat tremor or Parkinson-like symptoms, including deep brain stimulation or focused ultrasound. Other brain surgery rules you out only if the study doctor or sponsor’s chief medical officer thinks it could affect testing, diagnosis, safety, or study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Study sites (8)

AZ

FL

KS

KY

MI

TN