Environmental Epidemiology of Essential Tremor

NCT04576676 | Completed

• 2 other identifiers: STU-2020-0563R01NS094607
• Study Type: observational
• Target: 1,497
• Locations: 1 country
• Sites: 1

Brief Summary

This study's research is devoted to studying the causes of tremor, and especially essential tremor (ET), which is the most common type of tremor. Previous studies have revealed a link between harmane \[HA\], a dietary neurotoxin, and ET; these studies now also suggest a link between this toxin and Parkinson's disease (PD), a related tremor disorder. Yet these links are tentative rather than conclusively established; therefore, in this new patient-based proposal, which incorporates investigations spanning two continents (North America and Europe), utilizes several complementary study designs (prospective cohort, case control), and draws on several types of tissue (blood, brain), the investigator's goal is to nail down the links between HA and ET and to further solidify the emerging links between HA and PD.

Conditions

Essential Tremor; Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Level of Harmane in Blood

  Two vials of veinous blood will be collected from each participant and analyzed for the level of harmane. Specimen collection done at the Aston Care Center and sent to Purdue University for analysis.

  Day 1

• Archimedes Spirals

  Each participant will draw two spirals with each hand, used to assess the frequency and severity of one's tremor and to confirm their diagnosis.

  Day 1

• Video Interview

  After a participant has met the eligibility criteria, they participate in a two hour video interview, where a series of questionnaires is administered, as well as a videotaped neurological/movement assessment. Video is reviewed by study's PI and participant's tremor is rated on a fixed, numerical scale from 0.0 to 4.0, where 4.0 indicates a more severe tremor.

  Day 1

Secondary Outcomes (14)

• Cumulative Illness Rating Scale (CIRS)

  Day 1

• Montreal Cognitive Assessment (MoCA)

  Day 1

• Food Frequency Questionnaire

  Day 1

• Meat Questionnaire

  Day 1

• MDS-Unified Parkinson's Disease Rating Scale

  Day 1

Study Arms (4)

Essential Tremor

1. Subjects must be 50 years of age or older. 2. Subjects must have been diagnosed with Essential Tremor 3. Subjects must live within 3 hours of UTSW Subjects will be screened for eligibility over the phone, and if eligible, will partake in a virtual video conference with a research assistant. Subjects will also travel to the Aston Building at UTSW for a blood draw.

Parkinson's Disease

1. Subjects must be 50 years of age or older. 2. Subjects must have been diagnosed with Parkinson's Disease 3. Subjects must live within 3 hours of UTSW Subjects will be screened for eligibility over the phone, and if eligible, will partake in a virtual video conference with a research assistant. Subjects will also travel to the Aston Building at UTSW for a blood draw.

Healthy Individuals

1. Healthy individuals living within 3 hours of UTSW 2. Subjects must be 50 years of age or older 3. You are healthy and have not being diagnosed with any neurological disease Subjects will be screened for eligibility over the phone, and if eligible, will partake in a virtual video conference with a research assistant. Subjects will also travel to the Aston Building at UTSW for a blood draw.

Essential Tremor and Parkinson's Disease

1. Subjects must be 50 years of age or older. 2. Subjects must have been diagnosed with Essential Tremor 3. Subjects must have been diagnosed with Parkinson's Disease preceded by at least 3 years of enrollment in study 4. Subjects must live within 3 hours of UTSW Subjects will be screened for eligibility over the phone, and if eligible, will partake in a virtual video conference with a research assistant. Subjects will also travel to the Aston Building at UTSW for a blood draw.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals above the age of 50, living within a 3 hour driving radius of UT Southwestern.

You may qualify if:

• Essential Tremor
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Essential Tremor
• Subjects must live within 3 hours of UTSW
• Parkinson's Disease
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Parkinson's Disease
• Subjects must live within 3 hours of UTSW
• Healthy Individuals
• Healthy individuals living within 3 hours of UTSW
• Subjects must be 50 years of age or older
• You are healthy and have not being diagnosed with any neurological disease
• Essential Tremor and Parkinson's Disease
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Essential Tremor

You may not qualify if:

• Healthy Individuals
• Subjects with medical history of neurological conditions
• Subjects with family history of neurological condition
• Subjects with spouse diagnosed with Essential Tremor or Parkinson's Disease
• Essential Tremor
• Subjects with medical history of another movement disorder such as Parkinson's Disease or dystonia
• Subjects with head tremor that preceded hand tremor
• Parkinson's Disease
• Subjects with medical history of Essential Tremor
• Essential Tremor and Parkinson's Disease

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Purdue University: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Yale University: collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

Related Publications (16)

• Louis ED. Clinical practice. Essential tremor. N Engl J Med. 2001 Sep 20;345(12):887-91. doi: 10.1056/NEJMcp010928. No abstract available.

  PMID: 11565522 BACKGROUND

• Louis ED, Applegate LM, Factor-Litvak P, Parides MK, Andrews L. Essential tremor: occupational exposures to manganese and organic solvents. Neurology. 2004 Dec 14;63(11):2162-4. doi: 10.1212/01.wnl.0000145600.91491.f2.

  PMID: 15596771 BACKGROUND

• Louis ED, Benito-Leon J, Moreno-Garcia S, Vega S, Romero JP, Bermejo-Pareja F, Gerbin M, Viner AS, Factor-Litvak P, Jiang W, Zheng W. Blood harmane (1-methyl-9H-pyrido[3,4-b]indole) concentration in essential tremor cases in Spain. Neurotoxicology. 2013 Jan;34:264-8. doi: 10.1016/j.neuro.2012.09.004. Epub 2012 Sep 12.

  PMID: 22981972 BACKGROUND

• Louis ED, Zheng W, Applegate L, Shi L, Factor-Litvak P. Blood harmane concentrations and dietary protein consumption in essential tremor. Neurology. 2005 Aug 9;65(3):391-6. doi: 10.1212/01.wnl.0000172352.88359.2d.

  PMID: 16087903 BACKGROUND

• Bhalsing KS, Saini J, Pal PK. Understanding the pathophysiology of essential tremor through advanced neuroimaging: a review. J Neurol Sci. 2013 Dec 15;335(1-2):9-13. doi: 10.1016/j.jns.2013.09.003. Epub 2013 Sep 10.

  PMID: 24060292 BACKGROUND

• Benito-Leon J, Louis ED, Bermejo-Pareja F; Neurological Disorders in Central Spain Study Group. Risk of incident Parkinson's disease and parkinsonism in essential tremor: a population based study. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):423-5. doi: 10.1136/jnnp.2008.147223.

  PMID: 19289477 BACKGROUND

• Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838.

  PMID: 20175185 BACKGROUND

• Bain PG, Findley LJ, Thompson PD, Gresty MA, Rothwell JC, Harding AE, Marsden CD. A study of hereditary essential tremor. Brain. 1994 Aug;117 ( Pt 4):805-24. doi: 10.1093/brain/117.4.805.

  PMID: 7922467 BACKGROUND

• Louis ED, Benito-Leon J, Ottman R, Bermejo-Pareja F; Neurological Disorders in Central Spain (NEDICES) Study Group. A population-based study of mortality in essential tremor. Neurology. 2007 Nov 20;69(21):1982-9. doi: 10.1212/01.wnl.0000279339.87987.d7.

  PMID: 18025392 BACKGROUND

• Fekete R, Jankovic J. Revisiting the relationship between essential tremor and Parkinson's disease. Mov Disord. 2011 Feb 15;26(3):391-8. doi: 10.1002/mds.23512.

  PMID: 21462256 BACKGROUND

• MARSHALL J. Observations on essential tremor. J Neurol Neurosurg Psychiatry. 1962 May;25(2):122-5. doi: 10.1136/jnnp.25.2.122. No abstract available.

  PMID: 14470250 BACKGROUND

• Louis ED, Vonsattel JP, Honig LS, Lawton A, Moskowitz C, Ford B, Frucht S. Essential tremor associated with pathologic changes in the cerebellum. Arch Neurol. 2006 Aug;63(8):1189-93. doi: 10.1001/archneur.63.8.1189.

  PMID: 16908751 BACKGROUND

• Moncrieff J. Determination of pharmacological levels of harmane, harmine and harmaline in mammalian brain tissue, cerebrospinal fluid and plasma by high-performance liquid chromatography with fluorimetric detection. J Chromatogr. 1989 Nov 24;496(2):269-78. doi: 10.1016/s0378-4347(00)82576-1.

  PMID: 2613832 BACKGROUND

• Skog K, Solyakov A, Arvidsson P, Jagerstad M. Analysis of nonpolar heterocyclic amines in cooked foods and meat extracts using gas chromatography-mass spectrometry. J Chromatogr A. 1998 Apr 17;803(1-2):227-33. doi: 10.1016/s0021-9673(97)01266-1.

  PMID: 9604333 BACKGROUND

• Gironell A, Kulisevsky J, Barbanoj M, Lopez-Villegas D, Hernandez G, Pascual-Sedano B. A randomized placebo-controlled comparative trial of gabapentin and propranolol in essential tremor. Arch Neurol. 1999 Apr;56(4):475-80. doi: 10.1001/archneur.56.4.475.

  PMID: 10199338 BACKGROUND

• Benito-Leon J, Louis ED, Bermejo-Pareja F; Neurological Disorders in Central Spain (NEDICES) Study Group. Population-based case-control study of cognitive function in essential tremor. Neurology. 2006 Jan 10;66(1):69-74. doi: 10.1212/01.wnl.0000192393.05850.ec.

  PMID: 16401849 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

2 vials of veinous blood.

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nora C Hernandez, M.D.

  UTSW Medical Center

  STUDY DIRECTOR

• Allison Powell, BA

  UTSW Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Neurology

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 6, 2020
• Study Start: July 2, 2020
• Primary Completion: December 20, 2022
• Study Completion: July 19, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after the recruitment is complete and the biological samples have been analyzed.
• Access Criteria: The results and conclusions of our analysis will be shared at global scientific meetings and in the scientific literature (during publication in peer-reviewed journals). An additional mechanism of sharing data will be in the form of supplements to the additional data, which, for most journals, is on-line. The data will be entered into SPSS data files. Original data files for individual runs will be shared with colleagues who possess the means and knowledge to utilize them, under collaborative agreement. To strengthen data confidentiality and safeguard the privacy of study participants, we will make data available to approved researchers under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)