Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Recruiting
Observational Study
Essential Tremor, Movement DisordersEssential TremorEssential Tremor-plus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
CND Life Sciences · Other
Who this trial is looking for
This trial is looking for adults aged 50 to 85 with essential tremor. Participants will undergo a simple skin biopsy to help identify those at risk of developing Parkinson's disease.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 50 and 85 years old.
I have been diagnosed with essential tremor.
I have had my tremor for at least 3 years.
I am willing to participate in all study procedures.
I can provide written informed consent.
You may not be able to join if
I am under 50 or over 85 years old.
I have severe peripheral vascular disease.
I have active coronary or cerebrovascular disease.
I am on anticoagulant or dual anti-platelet therapy.
I have a history of alcoholism.
I have an allergic reaction to local anesthesia.
I have a history of impaired wound healing or keloid formation.
I have another neurodegenerative disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 prodro…
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
Trial Locations
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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 oth…
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.
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