Locked- in SyndromeNCT05444075
A Method for Communication With Arabic Patients Suffering From Classic Locked- in Syndrome
An observational study of Locked- in Syndrome, run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Locked- in Syndrome
- What is being tested?
- a method for communication
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 15 Apr 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- educated healthy subjects
Who cannot join
- non-educated, healthy subjects
- subjects with any sensory deficits
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Locked- in Syndrome
- Being tested
- a method for communication
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a method for communicationOther
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 group | Role | What they receive |
|---|---|---|
| subjects with preparatory education level | Ten subjects have a preparatory education level Receives: Other: a method for communication | |
| subjects with high school education | ten subjects with a high school education or its equivalent Receives: Other: a method for communication | |
| subjects with university education | ten subjects who have a university education, or are still in a university education stage Receives: Other: a method for communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alphabetic communication
The participant's ability to communicate in the Arabic alphabet using vertical eye movement
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locked- in SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Elnady, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444075
- Sponsor's protocol ID
- Soh-Med-22-03-39
- Status last verified
- Jun 2022
- First submitted
- 16 May 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method for Communication With Arabic Patients Suffering From Classic Locked- in Syndrome
- ClinicalTrials.gov ID
- NCT05444075
- Acronym / sponsor ID
- Soh-Med-22-03-39
- Conditions
- Locked- in Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subjects with preparatory education level | – | Other: a method for communicationTen subjects have a preparatory education level |
| subjects with high school education | – | Other: a method for communicationten subjects with a high school education or its equivalent |
| subjects with university education | – | Other: a method for communicationten subjects who have a university education, or are still in a university education stage |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- educated healthy subjects
Key exclusion criteria (2 listed)
- non-educated, healthy subjects
- subjects with any sensory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a method for communicationthe 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. | Other | subjects with high school education, subjects with preparatory education level, subjects with university education |
Primary outcome
Alphabetic communication
Time frame: up to 24 weeks
The participant's ability to communicate in the Arabic alphabet using vertical eye movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Locked- in Syndrome, run by Sohag University.
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 1 inclusion and 2 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alphabetic communication (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022; AzTrials last refreshed its copy on 29 Oct 2026.