Clinical Profile in Patients With Essential Tremors

Essential Tremor Clinical Trial

Official title:

Clinical Profile in Patients With Essential Tremors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05170022
• Other study ID #: essential tremors
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Zozil Mo zakaria, master
• Phone: 01015923507
• Email: zozilmahran[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Essential tremors are no longer a single motor disorder but disorder of movement associated with non-motor symptoms and the aim of this study is to explore the clinical profile of patients with essential tremors including motor and non-motor features and their relationship.

and to identify clinical predictors of these features.

Description:

Essential tremors (ET) was defined as mono-symptomatic tremor syndrome involving both upper limbs during action for at least 3 years, with or without tremor in other body parts . ET is considered the most prevalent adult movement disorder, The crude prevalence of ET varies widely from 0.08 to 220 cases per 1000 persons. Many pathological post-Mortem studies are providing evidence that ET is mostly can be recognizes as neurodegenerative disease of the cerebellum and brain stem .

In the last decade there is an emerging studies that discuss the presence of associated motor, non- motor, sensory and psychological symptoms besides the tremors . Motor features of ET are not confined to tremors. Another feature of ET is gait ataxia , Eye movement abnormalities of subclinical degree, difficulties in learning motor skills, Bradykinesia and slowness of finger tapping .

Studies of the last two decades reported mild cognitive deficits in patients with ET in comparison to healthy controls. These deficits affect number of cognitive domains, especially verbal memory, naming, verbal fluency, attention- concentration, working memory and concept formation . In addition ET was found to be associated with hearing impairment with abnormal threshold at higher tone frequencies which refer to sensorineural hearing loss, and olfactory deficits which both may points to cochlear pathology. Moreover, patients with ET thought to have higher incidence of depression and anxiety symptoms than age-matched healthy individuals correlated with tremors severity .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. All adults Patients are fulfilling cases definition of essential tremors will be included.

2. Gender: both sexes are included.

3. Any patient is, able to provide informed consent including permission to obtain information from patients' clinical medical history of at least three years' duration

Exclusion Criteria:

1. Patients are diagnosed with other neurological disorders unrelated to essential tremors.

2. Patients had any other condition presented with other cognitive or psychiatric disorders or known as drug abusers.

3. Patient had any systemic disease presented with tremors rather than essential tremors or compliant on medication had tremors side effect.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (18)

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Bermejo-Pareja F, Puertas-Martín V. Cognitive Features of Essential Tremor: A Review of the Clinical Aspects and Possible Mechanistic Underpinnings. Tremor and Other Hyperkinetic Movements [Internet]. 2012 Sep 14 [cited 2021 Oct 9];2(0). Available from: http://tremorjournal.org/articles/10.5334/tohm.106/

Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30. Review. — View Citation

Bologna M, Paparella G, Colella D, Cannavacciuolo A, Angelini L, Alunni-Fegatelli D, Guerra A, Berardelli A. Is there evidence of bradykinesia in essential tremor? Eur J Neurol. 2020 Aug;27(8):1501-1509. doi: 10.1111/ene.14312. Epub 2020 May 31. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Elbelkemy M, Shalash A, Mansour A, Hamed E, Abdelalim HM. Non motor symptoms in patients with essential tremor. QJM An Int J Med. 2020;113(Supplement_1):1-4.

Gitchel GT, Wetzel PA, Baron MS. Slowed saccades and increased square wave jerks in essential tremor. Tremor Other Hyperkinet Mov (N Y). 2013 Sep 3;3. pii: tre-03-178-4116-2. doi: 10.7916/D8251GXN. eCollection 2013. — View Citation

HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. — View Citation

Huang H, Yang X, Zhao Q, Ning P, Shen Q, Wang H, Xie D, Lu H, Xu Y. Clinical characteristics of patients with essential tremor or essential tremor plus. Acta Neurol Scand. 2020 Apr;141(4):335-341. doi: 10.1111/ane.13209. Epub 2020 Jan 6. — View Citation

Louis ED, Joyce JL, Cosentino S. Mind the gaps: What we don't know about cognitive impairment in essential tremor. Parkinsonism Relat Disord [Internet]. 2019 Jun 1 [cited 2021 Oct 9];63:10-9. Available from: http://www.prd-journal.com/article/S1353802019300860/fulltext

Rahman TT, El Gaafary MM. Montreal Cognitive Assessment Arabic version: reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo. Geriatr Gerontol Int. 2009 Mar;9(1):54-61. doi: 10.1111/j.1447-0594.2008.00509.x. — View Citation

Rao AK, Louis ED. Ataxic Gait in Essential Tremor: A Disease-Associated Feature? Tremor and Other Hyperkinetic Movements [Internet]. 2019 Jun 19 [cited 2021 Oct 9];9(0). Available from: http://tremorjournal.org/articles/10.5334/tohm.507/

Shalash AS, Mohamed H, Mansour AH, Elkady A, Elrassas H, Hamid E, Elbalkimy MH. Clinical Profile of Non-Motor Symptoms in Patients with Essential Tremor: Impact on Quality of Life and Age-Related Differences. Tremor Other Hyperkinet Mov (N Y). 2019 Dec 6;9. doi: 10.7916/tohm.v0.736. eCollection 2019. — View Citation

Shill HA, Adler CH, Sabbagh MN, Connor DJ, Caviness JN, Hentz JG, Beach TG. Pathologic findings in prospectively ascertained essential tremor subjects. Neurology. 2008 Apr 15;70(16 Pt 2):1452-5. doi: 10.1212/01.wnl.0000310425.76205.02. — View Citation

Shill HA, De La Vega FJ, Samanta J, Stacy M. Motor learning in essential tremor. Mov Disord. 2009 Apr 30;24(6):926-8. doi: 10.1002/mds.22479. — View Citation

Wechsler memory scale. - PsycNET [Internet]. [cited 2021 Oct 25]. Available from: https://psycnet.apa.org/record/1946-00348-000

Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. — View Citation

Yilmaz NH, Akbostanci MC, Yilmaz N. Sensorineural Hearing Loss in Non-depressed Essential Tremor Cases and Controls: A Clinical and Audiometric Study. Tremor and Other Hyperkinetic Movements [Internet]. 2015 Jan 29 [cited 2021 Oct 9];5(0):281. Available from: http://tremorjournal.org/articles/10.5334/tohm.237

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine clinical profile including motor and non-motor features in these patients	describing the motor and non-motor associations ( cognitive , psychological and sensory )with essential tremors.	3 years
Secondary	To identify clinical predictors of these features.	Determine the clinical predictors for these features in these ET patients and impact on their quality of life.	3 years