Clinical Profile in Patients With Essential Tremors

January 13, 2022 updated by: Zozil yousef zakaria, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 .

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine clinical profile including motor and non-motor features in these patients
Time Frame: 3 years
describing the motor and non-motor associations ( cognitive , psychological and sensory )with essential tremors.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify clinical predictors of these features.
Time Frame: 3 years
Determine the clinical predictors for these features in these ET patients and impact on their quality of life.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Noha Abo-lftoh, prof. doctor, hospital medical school affiliation
  • Study Director: Nourelhoda Ah Haridy, doctor, hospital medical school affiliation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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