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Essential TremorNCT05170022

Clinical Profile in Patients With Essential Tremors

An observational study of Essential Tremor, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Essential Tremor
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to 1 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All cases are recruited in the study period; six months duration since date of approval of ethical committee of Assiut University hospitals and postgraduate committee of Faculty of Medicine, Assiut University.

Who may be able to join

  • All adults Patients are fulfilling cases definition of essential tremors will be included.
  • Gender: both sexes are included.
  • Any patient is, able to provide informed consent including permission to obtain information from patients' clinical medical history of at least three years' duration

Who cannot join

  • Patients are diagnosed with other neurological disorders unrelated to essential tremors.
  • Patients had any other condition presented with other cognitive or psychiatric disorders or known as drug abusers.
  • Patient had any systemic disease presented with tremors rather than essential tremors or compliant on medication had tremors side effect.

Trial locations and contacts

1 site in 1 country.

Zozil Mo zakaria, master contact

01015923507

zozilmahran@gmail.com

Noha Mo Abo-lftoh, professor contact

01006800910

noha_ahmed_re@yahoo.com

Egypt1 site

  • Assiut university

    Asyut

Other trials in Egypt

About this study

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.

Read the detailed 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 .

Medical subject headings
Essential Tremor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (1)

  1. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05170022
Sponsor's protocol ID
essential tremors
Status last verified
Jan 2022
First submitted
10 Dec 2021
Last updated
18 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

  • 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.

    PubMed 29193359

  • 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.

    PubMed 31863462

  • 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.

    PubMed 31413894

  • 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.

    PubMed 24116343

  • 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.

    PubMed 19243062

  • 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.

    PubMed 32396976

  • 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.

    PubMed 30876840

  • 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.

    PubMed 23440004

  • 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.

    PubMed 25667817

  • 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.

    PubMed 31867132

  • 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.

    PubMed 19260980

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

  • 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

  • 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.

    PubMed 2748771

Questions about this trial

What is this clinical trial studying?

An observational study of Essential Tremor, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zozil Mo zakaria, master (01015923507, zozilmahran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine clinical profile including motor and non-motor features in these patients (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05170022, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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