A Method for Communication With Arabic Patients Suffering From Classic Locked- in Syndrome

Aim of the work The aim of this study is to test an Arabic alphabet communication system designed to train physicians to communicate with Arabic-speaking patients with LIS.

Subjects and methods

• Place of study: Department of Neurology at Sohag university hospital
• Type of study: clinical trial.
• Subjects: Thirty healthy subjects from three different educational levels. Ten subjects have a preparatory education level, ten subjects with a high school education or its equivalent, and ten subjects who have a university education or are still in a university education stage. They will be collected from among patients' relatives and employees of Sohag University Hospital.

Methods of the study: The method shown in the figure No. 1 is the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor.

The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks.

The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence.

After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.

Study Overview

• Status: Not yet recruiting
• Conditions: Locked- in Syndrome
• Intervention / Treatment: Other: a method for communication

Detailed Description

Aim of the work The aim of this study is to test an Arabic alphabet communication system designed to train physicians to communicate with Arabic-speaking patients with LIS.

Subjects and methods

• Place of study: Department of Neurology at Sohag university hospital
• Type of study: clinical trial.
• Subjects: Thirty healthy subjects from three different educational levels. Ten subjects have a preparatory education level, ten subjects with a high school education or its equivalent, and ten subjects who have a university education or are still in a university education stage. They will be collected from among patients' relatives and employees of Sohag University Hospital.

Methods of the study: the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor.

The Arabic alphabet was divided into 4 groups and it was taken into account - as far as possible - to include letters of similar shape in the same group. Each group is listed on a separate line and given a number from 1 to 4 in addition to the letters, each line includes an option at the end of it to enable the person to change the line.

A fifth line has also been added that contains options for ending the word, ending the sentence, choosing numbers (which were included in a separate sixth line from 0 to 9) in addition to an option to change the line depends on the vertical eye movement or the blink of the eye lid and will be used in both ways.

The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks.

The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence.

After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.

The researcher will present the subject a piece of paper on which is written all of the information that has to be communicated to the doctor. The researcher will notice that the method of communication was solely based on eye or eyelid movement, and if the person completes the communication in any other way (such as speech or head or hand movement), the attempt will be considered incorrect and will be repeated with a different piece of information.

For each person, at least four successful attempts with four different pieces of information will be made. Three of them will be information from the researcher to the person who will deliver it to the doctor, and the fourth will be a question from the doctor to the person who will then receive an answer from him.

A successful attempt is one that is made in the correct manner, regardless of whether the translated information is correct or incorrect.

All data will be collected, tabulated and statistically analyzed.

References Bauer, G., F. Gerstenbrand and E. Rumpl (1979). "Varieties of the locked-in syndrome." Journal of Neurology 221(2): 77-91.

Chisholm, N. and G. Gillett (2005). "The patient's journey: Living with locked-in syndrome." Bmj 331(7508): 94-97.

Khanna, K., A. Verma and B. Richard (2011). ""The locked-in syndrome": Can it be unlocked?" Journal of Clinical Gerontology and Geriatrics 2(4): 96-99.

Laureys, S., F. Pellas, P. Van Eeckhout, S. Ghorbel, C. Schnakers, F. Perrin, J. Berré, M.-E. Faymonville, K.-H. Pantke, F. Damas, M. Lamy, G. Moonen and S. Goldman (2005). The locked-in syndrome : what is it like to be conscious but paralyzed and voiceless? Progress in Brain Research. S. Laureys, Elsevier. 150: 495-611.

Smith, E. and M. Delargy (2005). "Locked-in syndrome." BMJ 330(7488): 406.

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thirty healthy subjects from three different educational levels. Ten subjects have a preparatory education level, ten subjects with a high school education or its equivalent, and ten subjects who have a university education or are still in a university education stage. They will be collected from among patients' relatives and employees of Sohag University Hospital.

Description

Inclusion Criteria:

• educated healthy subjects

Exclusion Criteria:

• non-educated, healthy subjects
• subjects with any sensory deficits

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subjects with preparatory education level; Ten subjects have a preparatory education level	Other: a method for communication; the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor. The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks. The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence. After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.
subjects with high school education; ten subjects with a high school education or its equivalent	Other: a method for communication; the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor. The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks. The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence. After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.
subjects with university education; ten subjects who have a university education, or are still in a university education stage	Other: a method for communication; the Arabic alphabet (arranged in the traditional order) printed on double-sided cardboard, with one copy facing the person and one facing the doctor. The code will be in the case of a positive selection (the desired line or letter) by looking up or one blink, but in the case of a negative selection (not the desired line or letter), it will be by looking down or two blinks. The person will choose the letters of each word and then choose the end of the word and after selecting all the words of the sentence choose the end of the sentence. After the strategy has been taught to the subject, he or she will be asked to communicate with the physician using this way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alphabetic communication	The participant's ability to communicate in the Arabic alphabet using vertical eye movement	up to 24 weeks

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Neuromuscular Diseases; Paralysis; Syndrome; Quadriplegia; Locked-In Syndrome
• Other Study ID Numbers: Soh-Med-22-03-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No