Simple skin test may spot Parkinson's risk years early
NCT ID NCT07428447
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times
Summary
This study is testing whether a skin biopsy can detect abnormal proteins linked to Parkinson's disease in people with essential tremor, a common movement disorder. Researchers will follow 300 participants aged 50-85 for two years to see who develops Parkinson's. The goal is to find a simple, less invasive way to identify those at highest risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Syn-One Test (skin biopsy for phosphorylated alpha-synuclein)
- What this could lead to
- If successful, this could lead to a simple skin test that identifies which people with essential tremor are at high risk of developing Parkinson's disease, enabling earlier monitoring or intervention.
- What could go wrong
- This is an observational study, not a treatment trial. The test may not accurately predict progression, and results may not apply to all patients. It is still early, with only 300 participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects will be enrolled from up to 18 sites across the US from academic institutions and private clinics.
- Ages
-
50 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Essential tremor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
CND Clinical Research Center
RECRUITINGScottsdale, Arizona, 85258, United States
-
Neurology One
RECRUITINGOrlando, Florida, 32825, United States
-
Norton Healthcare
RECRUITINGLouisville, Kentucky, 40202, United States
-
Veracity Neurosciences LLC
RECRUITINGMemphis, Tennessee, 38157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Hair-Thin electrodes tested to Fine-Tune brain stimulation
- Brain training through implanted electrodes aims to quiet Parkinson's tremors
- Can new brain stimulation patterns quiet stubborn tremors?
- AI hunts for early clues to Parkinson's and Alzheimer's progression
- Mapping the Brain's electrical signals to improve surgical precision