Clinical Profile in Patients With Essential Tremors

NCT ID: NCT05170022

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Tremor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zozil yousef zakaria

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noha Abo-lftoh, prof. doctor

Role: STUDY_DIRECTOR

hospital medical school affiliation

Nourelhoda Ah Haridy, doctor

Role: STUDY_DIRECTOR

hospital medical school affiliation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zozil Mo zakaria, master

Role: CONTACT

01015923507

Noha Mo Abo-lftoh, professor

Role: CONTACT

01006800910

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29193359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31863462 (View on PubMed)

Rao AK, Louis ED. Ataxic Gait in Essential Tremor: A Disease-Associated Feature? Tremor Other Hyperkinet Mov (N Y). 2019 Jun 19;9. doi: 10.7916/d8-28jq-8t52. eCollection 2019.

Reference Type BACKGROUND
PMID: 31413894 (View on PubMed)

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:tre-03-178-4116-2. doi: 10.7916/D8251GXN. eCollection 2013.

Reference Type BACKGROUND
PMID: 24116343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19243062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32396976 (View on PubMed)

Louis ED, Joyce JL, Cosentino S. Mind the gaps: What we don't know about cognitive impairment in essential tremor. Parkinsonism Relat Disord. 2019 Jun;63:10-19. doi: 10.1016/j.parkreldis.2019.02.038. Epub 2019 Mar 1.

Reference Type BACKGROUND
PMID: 30876840 (View on PubMed)

Bermejo-Pareja F, Puertas-Martin V. Cognitive features of essential tremor: a review of the clinical aspects and possible mechanistic underpinnings. Tremor Other Hyperkinet Mov (N Y). 2012;2:02-74-541-1. doi: 10.7916/D89W0D7W. Epub 2012 Sep 14.

Reference Type BACKGROUND
PMID: 23440004 (View on PubMed)

Yilmaz NH, Akbostanci MC, Yilmaz N. Sensorineural Hearing Loss in Non-depressed Essential Tremor Cases and Controls: A Clinical and Audiometric Study. Tremor Other Hyperkinet Mov (N Y). 2015 Jan 29;5:281. doi: 10.7916/D8XW4HKQ. eCollection 2015.

Reference Type BACKGROUND
PMID: 25667817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31867132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19260980 (View on PubMed)

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

Reference Type BACKGROUND

36-Item Short Form Survey (SF-36) Scoring Instructions | RAND [Internet]. [cited 2021 Oct 23]. Available from: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html

Reference Type BACKGROUND

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. doi: 10.1016/0165-1781(89)90047-4.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

Reference Type BACKGROUND
PMID: 13638508 (View on PubMed)

Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.

Reference Type BACKGROUND
PMID: 3395203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18413570 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

essential tremors

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.