Traumatic Brain Injury With Loss of ConsciousnessNCT05521815
Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
A study testing Coma arousal therapy and Selected physiotherapy program in people with Traumatic Brain Injury With Loss of Consciousness, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients. BACKGROUND: Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Traumatic Brain Injury With Loss of Consciousness
- What is being tested?
- Coma arousal therapy and Selected physiotherapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2022to 30 Nov 2023
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Traumatic brain injury with GCS score 3-12.
- Age range from 20-50 years old.
- Must be medically stable post trauma 29
Who cannot join
- Patient with other neurological deficits or orthopedic abnormalities that causing disability.
- Patients with pre injury psychiatric disorders.
- Patients with pre injury cognitive disorders.
- Patients who performed surgery post traumatic brain injury.
- Patients not taking the same medications.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE:
The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients.
Read more
BACKGROUND:
Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year.
The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).
Read the detailed description
The aim of this study is to examine the early effect of coma arousal therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury. forty two patients will be selected and they will be assigned in to two different group, a study group where will they recieve coma arousal therapy in addition to conventional therapy and a control group where they will recieve only the conventional physical therapy program.
- Being tested
- Coma arousal therapy, Selected physiotherapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma arousal therapyOther
early coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs).
Selected physiotherapy programOther
selected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The group that are going to receive the coma arousal therapy program Receives: Other: Coma arousal therapy |
| Control group | Placebo comparator | This group will receive only traditional treatment program Receives: Other: Selected physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
conscious level
is defined as the state of awareness of the self and environment with appropriate arousal or wakefulness. conscious level will be measured using glascow coma scale (GCS), which is a scale used to objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients. The highest possible GCS score is 15, and the lowest is 3. A score of 15 means you're fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means you're in a coma. The lower the score, the deeper the coma is.
Measured: One and half year
Cognition
'cognition' refers to all the processes by which the sensory input is transformed, reduced, elaborated, stored, recovered, and used. It is concerned with these processes even when they operate in the absence of relevant stimulation, as in images and hallucinations. cognition will be measured using Rancho Los Amigos Revised Scale (RLAS-R), its a scale used by both medical and rehabilitation providers to measure and track cognitive recovery after traumatic brain injury. It is a 10-point scale where Level I indicates No response/total assistance and Level X indicates Purposeful, appropriate/ modified independent.
Measured: One and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start23 Aug 2022
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Loss of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Samir Mohamed Amin Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521815
- Sponsor's protocol ID
- 54531
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05521815
- Acronym / sponsor ID
- 54531
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Aug 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.
PURPOSE:
The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients.
BACKGROUND:
Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year.
The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).
Detailed description
The aim of this study is to examine the early effect of coma arousal therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury. forty two patients will be selected and they will be assigned in to two different group, a study group where will they recieve coma arousal therapy in addition to conventional therapy and a control group where they will recieve only the conventional physical therapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Coma arousal therapyThe group that are going to receive the coma arousal therapy program |
| Control group | Placebo comparator | Other: Selected physiotherapy programThis group will receive only traditional treatment program |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders.
- Traumatic brain injury with GCS score 3-12.
- Age range from 20-50 years old.
- Must be medically stable post trauma 29
Key exclusion criteria (5 listed)
- Patient with other neurological deficits or orthopedic abnormalities that causing disability.
- Patients with pre injury psychiatric disorders.
- Patients with pre injury cognitive disorders.
- Patients who performed surgery post traumatic brain injury.
- Patients not taking the same medications.
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 |
|---|---|---|
| Coma arousal therapyearly coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs). | Other | Study group |
| Selected physiotherapy programselected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs). | Other | Control group |
Primary outcome
conscious level
Time frame: One and half year
is defined as the state of awareness of the self and environment with appropriate arousal or wakefulness. conscious level will be measured using glascow coma scale (GCS), which is a scale used to objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients. The highest possible GCS score is 15, and the lowest is 3. A score of 15 means you're fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means you're in a coma. The lower the score, the deeper the coma is.
Cognition
Time frame: One and half year
'cognition' refers to all the processes by which the sensory input is transformed, reduced, elaborated, stored, recovered, and used. It is concerned with these processes even when they operate in the absence of relevant stimulation, as in images and hallucinations. cognition will be measured using Rancho Los Amigos Revised Scale (RLAS-R), its a scale used by both medical and rehabilitation providers to measure and track cognitive recovery after traumatic brain injury. It is a 10-point scale where Level I indicates No response/total assistance and Level X indicates Purposeful, appropriate/ modified independent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coma arousal therapy and Selected physiotherapy program in people with Traumatic Brain Injury With Loss of Consciousness, run by Cairo 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
conscious level (time frame: One and half year). The study lists 2 primary outcomes in all. 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 14 Dec 2023.