Patients With Traumatic Brain InjuryNCT07537023
Family-Centered Affective Stimulation for Patients With Traumatic Brain Injury: Its Effects on Coma Recovery
A study testing Family-Centered Affective Stimulation (FCAS) in people with Patients With Traumatic Brain Injury and Coma, Traumatic, run by Cairo University at 1 site in Egypt.
Trial summary
Family-centered affective stimulation involves creating an environment in which family members actively participate in the patient's recovery by providing emotional support, positive reinforcement, and a supportive presence. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Traumatic Brain Injury, Coma, Traumatic
- What is being tested?
- Family-Centered Affective Stimulation (FCAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2025to 30 Oct 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- comprised adult patients admitted to the intensive care unit
- adults who were diagnosed with traumatic brain injury (TBI)
- the patients are ranging from mild to severe, with a Glasgow Coma Scale (GCS) score of 5-8
- the patients without significant co-existing medical or psychiatric conditions that could affect recovery.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Family-centered affective stimulation involves creating an environment in which family members actively participate in the patient's recovery by providing emotional support, positive reinforcement, and a supportive presence. The family-centered affective simulation effects on coma recovery in patients afflicted with traumatic brain injury were the aim of this study.
A quasi-experimental design was employed with 120 patients, who were assigned to either the family stimulation group (n = 60) or the control group (n = 60) in a random manner. Validated instruments, encompassing the Modified Early Warning Score (MEWS), Full Outline of Unresponsiveness (FOUR) score, and Coma Recovery Scale-Revised (CRS-R), were used to assess outcomes of coma recovery. Chi-square tests, independent and paired t-tests, and correlation coefficients were employed to analyze the data.
Read more
Following the implementation of family stimulation, highly statistically significant differences were evident in patients' deterioration risk scores, consciousness level scores, and mean coma recovery scores among the studied groups (p = 0.001). Additionally, the family stimulation group showed significant improvement between pre- and post-study phases (p < 0.001).
The application of family-centered organized affective stimulation is an efficient and practical approach to enhance consciousness levels and coma recovery outcomes in comatose patients. Nurses can integrate sensory stimulation into existing therapeutic interventions, either independently or in collaboration with patients' families.
Read the detailed description
Traumatic brain injury poses as remarkable health burden worldwide, with about 69 million cases in the world every year. It can lead to a wide range of cognitive, emotional, and physical impairments, profoundly impacting both patients and their families. Recovery from TBI is a complex and multifaceted process that often requires not only medical and rehabilitative interventions but also comprehensive psychosocial and emotional support.
Acute or severe brain injury is among the most life-threatening consequences related to cerebral hemorrhage or traumatic injury. Prolonged coma is associated with worsening long-term cognitive, behavioral, and emotional impairments, which significantly limit patients' ability to resume normal activities. Multimodal sensory stimulation is an intervention aimed at enhancing arousal, awareness, and behavioral responses through the systematic activation of multiple sensory pathways. Exposure to sensory stimulation has been shown to promote dendritic growth and improve cognitive functioning in addition to social interaction. Accordingly, this study was concerned with determining the impact of multimodal sensory stimulation upon consciousness level across unconscious patients.
Disturbed level of consciousness (DOC) refer to a range of impairments in conscious state that may arise following traumatic brain injury (TBI) or stroke. Consciousness is generally understood to consist of two key elements: wakefulness, indicated by the opening of the eyes in response to external stimuli, and awareness, demonstrated through measurable behavioral and physical reactions. The DOC progression starts within occurrence of injury and continues through the emergency stage to management in the intensive care unit (ICU). The acute stage commonly covers the initial 28 days after the injury occurs. In recent decades, developments in clinical management and neuroscience have fostered greater optimism about the possibility of meaningful recovery for certain patients impacted by TBI.
Traumatic brain injury (TBI) is now widely viewed as a long-term health condition, as accumulating evidence indicates that its consequences can persist for extended periods, particularly in cases of moderate to severe injury. Although many patients with mild TBI experience recovery within a relatively short time, recent research suggests that symptoms in both children and adults may continue for a year or even longer. These observations highlight the importance of enhancing follow-up care and implementing long-term management approaches that are tailored to different age groups.
One emerging scope of interest in TBI recovery is the role of family involvement, particularly through interventions aimed at enhancing affective stimulation. Family-centered care, which places the family at the core of the patient's recovery process, has been identified as a critical component in improving outcomes for individuals with TBI.
Recent research emphasizes the essential role of family involvement in the rehabilitation process, particularly in providing emotional and affective support. Family-centered care (FCC) has emerged as a key model of care delivery, promoting collaboration between healthcare providers and family members to support patients holistically. FCC has been associated with improved recovery outcomes and may reduce healthcare costs by decreasing the need for prolonged hospital stays or frequent medical interventions. Within this framework, family-centered affective stimulation including structured emotional and psychosocial engagement by family members, has gained attention as an effective strategy to enhance recovery as well as functional outcomes in patients with traumatic brain injury (TBI).
It had been revealed by a systematic review and meta-analysis that it is more efficient to early stimulation family-centered sensory and affective than routine care or nurse-implemented sensory stimulation in terms of enhancing both the level of consciousness and cognitive functioning in comatose patients with traumatic brain injury. Furthermore, the review indicated that in terms of recovery outcomes promotion, multi-sensory stimulation turned out to be more efficient than single-modality stimulation.
- Being tested
- Family-Centered Affective Stimulation (FCAS)
- Keywords
- effective stimulation, Coma Recovery, Consciousness Level, Family-Centered Care, Traumatic Brain Injury
- Medical subject headings
- Coma, Post-Head Injury, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Centered Affective Stimulation (FCAS)Behavioural
Family members were guided to provide structured emotional and sensory stimulation, including verbal communication, familiar voices, emotional reassurance, and gentle touch, in accordance with the prescribed protocol. The intervention was administered for a specified duration and frequency, under continuous clinical supervision to ensure patient safety and adherence to the protocol. During the intervention period, patients were continuously monitored, and periodic assessments were conducted to evaluate their responses. Changes in level of consciousness, behavioral reactions, and physiological parameters were observed and documented at regular intervals. The research team closely supervised the sessions to ensure consistency and provided ongoing support to participating family members. Any adverse responses or deviations from the protocol were promptly recorded and addressed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Family-Centered Affective Stimulation (FCAS) | Experimental | The intervention phase involved the systematic implementation of Family-Centered Affective Stimulation (FCAS). Family members were guided to provide structured emotional and sensory stimulation, including verbal communication, familiar voices, emotional reassurance, and gentle touch, in accordance with the prescribed protocol. The intervention was administered for a specified duration and frequency, under continuous clinical supervision to ensure patient safety and adherence to the protocol. During the intervention period, patients were continuously monitored, and periodic assessments were conducted to evaluate their responses. Changes in level of consciousness, behavioral reactions, and physiological parameters were observed and documented at regular intervals. The research team closely supervised the sessions to ensure consistency and provided ongoing support to participating family members. Any adverse responses or deviations from the protocol were promptly recorded and addressed. Receives: Behavioral: Family-Centered Affective Stimulation (FCAS) |
| Control group: Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Assessment
The Coma Recovery Assessment is a standardized tool designed to measure neurobehavioral function. The Coma Recovery Scale-Revised (CRS-R) is a reference standard for assessing neurobehavioral function and diagnosing disorders of consciousness. It is made up by six subscales: auditory, visual, motor, or motor/verbal, communication, and arousal. The items of CRS-R as well as rating scale categories were refined to enhance clinical utility, construct validity, and diagnostic accuracy. Each subscale follows a hierarchical scoring system, with higher scores indicating greater neurobehavioral function. The number of scoring categories differs across the subscales. For example, the communication subscale includes three response options (0, 1, and 2), while the motor subscale contains seven categories ranging from 0 to 6. Consequently, the total raw score of the CRS-R can vary between 0 and 23.
Measured: Two timepoints, : T0 at baseline and at T1 at 6 months
Secondary outcomes (2)
Modified Early Warning Score (MEWS)
The Modified Early Warning Score (MEWS) provides a simple and practical model for measuring risk of illness deterioration, with higher scores indicating an increased likelihood of clinical decline. Vital signs and level of consciousness are assessed on a five-point scale ranging from 0 to 4. The scoring system was adopted from Veldhuis et al. to assess physiological parameters and identify early indicators of deterioration, including vital signs and level of consciousness. This Early Warning Score (EWS) provides a simple and practical model for evaluating illness severity, with higher scores indicating an increased likelihood of clinical decline. Vital signs and level of consciousness are assessed on a five-point scale ranging from 0 to 4. Total scores are categorized as follows: 0-4, low risk of deterioration; 5-6, moderate risk; and ≥7, high risk, requiring immediate clinical attention
Measured: Two timepoints, : T0 at baseline and at T1 at 6 months
Full Outline of Unresponsiveness (FOUR) Score
The Full Outline of Unresponsiveness (FOUR) score is a recently validated coma scale used to evaluate the level of consciousness. The Full Outline of Unresponsiveness (FOUR) score is a recently validated coma scale used to evaluate the level of consciousness. It was adopted from Wijdicks et al. (2005). The scale consists of four components, each with a maximum score of four: eye response (E4), motor response (M4), brainstem reflexes (B4), and respiration (R4). Each component is scored on a five-point scale ranging from 0 to 4. Total scores are interpreted as follows: 15-16, conscious; 8-14, semiconscious; and 0-7, unconscious. The FOUR score provides a comprehensive assessment of neurological function, including bra
Measured: Two timepoints, : T0 at baseline and at T1 at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start2 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Patients With Traumatic Brain InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Helwan University
- Responsible party
- Principal investigator, Mahmoud Ahmed Ahmed Ahmed Elsheikh, Cairo University
- Investigators
- Walid Elsayed Hemaida, PhD, Study chair, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537023
- Sponsor's protocol ID
- HUNURSERC42
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
Publications
25. Peterson AB, Thomas KE, Zhou H. Surveillance report of traumatic brain injury-related deaths by age group, sex, and mechanism of injury-United States, 2018 and 2019.
Tien HY, Su JS, Yu WY, Pan ML, Yang YC, Chiou YJ, Chen CY, Wu CK, Chen HM, Chen CY, Huei-Ming Ma M. Leveraging the Modified Early Warning Score (MEWS) in rapid response teams to predict and prevent ICU readmissions. J Formos Med Assoc. 2025 Jun 9:S0929-6646(25)00283-9. doi: 10.1016/j.jfma.2025.06.009. Online ahead of print.
PubMed 40494742Ahmed FR, Attia AK, Mansour H, Megahed M. Outcomes of family-centred auditory and tactile stimulation implementation on traumatic brain injured patients. Nurs Open. 2023 Mar;10(3):1601-1610. doi: 10.1002/nop2.1412. Epub 2022 Oct 27.
PubMed 36303273Adineh M, Elahi N, Molavynejad S, Jahani S, Savaie M. Impact of a sensory stimulation program conducted by family members on the consciousness and pain levels of ICU patients: A mixed method study. Front Med (Lausanne). 2022 Sep 20;9:931304. doi: 10.3389/fmed.2022.931304. eCollection 2022.
PubMed 36203763Weaver JA, Cogan AM, O'Brien KA, Hansen P, Giacino JT, Whyte J, Bender Pape T, van der Wees P, Mallinson T. Determining the Hierarchy of Coma Recovery Scale-Revised Rating Scale Categories and Alignment with Aspen Consensus Criteria for Patients with Brain Injury: A Rasch Analysis. J Neurotrauma. 2022 Oct;39(19-20):1417-1428. doi: 10.1089/neu.2022.0095. Epub 2022 Jun 16.
PubMed 3557072513. Chandrasekharan S, Sreedharan J, Gopakumar A. Statistical issues in small and large sample: Need of optimum upper bound for the sample size. Int J Comput Theor Stat. 2019;6(2):108-118.
11. Maciejewski ML. Quasi-experimental design. Biostat Epidemiol. 2020;4(1):38-47. doi:10.1080/24709360.2018.1477468.
Zuo J, Tao Y, Liu M, Feng L, Yang Y, Liao L. The effect of family-centered sensory and affective stimulation on comatose patients with traumatic brain injury: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103846. doi: 10.1016/j.ijnurstu.2020.103846. Epub 2020 Dec 7.
PubMed 33485101Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, Di H, Schnakers C. Do Sensory Stimulation Programs Have an Impact on Consciousness Recovery? Front Neurol. 2018 Oct 2;9:826. doi: 10.3389/fneur.2018.00826. eCollection 2018.
PubMed 30333789Carrier SL, Ponsford J, McKay A. Family experiences of supporting a relative with agitation during early recovery after traumatic brain injury. Neuropsychol Rehabil. 2024 May;34(4):510-534. doi: 10.1080/09602011.2023.2219064. Epub 2023 Jun 18.
PubMed 37332244Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14.
PubMed 333186752. Lewis CC, Lobo D. Effectiveness of the multi-modal sensory stimulation on the level of consciousness among unconscious patients. J Health Allied Sci NU. 2026;16:26. doi:10.25259/JHS-2024-3-5-R4-(1280).
Muili AO, Kuol PP, Jobran AWM, Lawal RA, Agamy AA, Bankole NDA. Management of traumatic brain injury in Africa: challenges and opportunities. Int J Surg. 2024 Jun 1;110(6):3760-3767. doi: 10.1097/JS9.0000000000001391.
PubMed 38573135
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Affective Stimulation for Patients With Traumatic Brain Injury: Its Effects on Coma Recovery
- ClinicalTrials.gov ID
- NCT07537023
- Acronym / sponsor ID
- HUNURSERC42
- Keywords
- effective stimulation, Coma Recovery, Consciousness Level, Family-Centered Care, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Helwan University
- Study start
- 2 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 17 Apr 2026 (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.
Family-centered affective stimulation involves creating an environment in which family members actively participate in the patient's recovery by providing emotional support, positive reinforcement, and a supportive presence. The family-centered affective simulation effects on coma recovery in patients afflicted with traumatic brain injury were the aim of this study.
A quasi-experimental design was employed with 120 patients, who were assigned to either the family stimulation group (n = 60) or the control group (n = 60) in a random manner. Validated instruments, encompassing the Modified Early Warning Score (MEWS), Full Outline of Unresponsiveness (FOUR) score, and Coma Recovery Scale-Revised (CRS-R), were used to assess outcomes of coma recovery. Chi-square tests, independent and paired t-tests, and correlation coefficients were employed to analyze the data.
Following the implementation of family stimulation, highly statistically significant differences were evident in patients' deterioration risk scores, consciousness level scores, and mean coma recovery scores among the studied groups (p = 0.001). Additionally, the family stimulation group showed significant improvement between pre- and post-study phases (p < 0.001).
The application of family-centered organized affective stimulation is an efficient and practical approach to enhance consciousness levels and coma recovery outcomes in comatose patients. Nurses can integrate sensory stimulation into existing therapeutic interventions, either independently or in collaboration with patients' families.
Detailed description
Traumatic brain injury poses as remarkable health burden worldwide, with about 69 million cases in the world every year. It can lead to a wide range of cognitive, emotional, and physical impairments, profoundly impacting both patients and their families. Recovery from TBI is a complex and multifaceted process that often requires not only medical and rehabilitative interventions but also comprehensive psychosocial and emotional support.
Acute or severe brain injury is among the most life-threatening consequences related to cerebral hemorrhage or traumatic injury. Prolonged coma is associated with worsening long-term cognitive, behavioral, and emotional impairments, which significantly limit patients' ability to resume normal activities. Multimodal sensory stimulation is an intervention aimed at enhancing arousal, awareness, and behavioral responses through the systematic activation of multiple sensory pathways. Exposure to sensory stimulation has been shown to promote dendritic growth and improve cognitive functioning in addition to social interaction. Accordingly, this study was concerned with determining the impact of multimodal sensory stimulation upon consciousness level across unconscious patients.
Disturbed level of consciousness (DOC) refer to a range of impairments in conscious state that may arise following traumatic brain injury (TBI) or stroke. Consciousness is generally understood to consist of two key elements: wakefulness, indicated by the opening of the eyes in response to external stimuli, and awareness, demonstrated through measurable behavioral and physical reactions. The DOC progression starts within occurrence of injury and continues through the emergency stage to management in the intensive care unit (ICU). The acute stage commonly covers the initial 28 days after the injury occurs. In recent decades, developments in clinical management and neuroscience have fostered greater optimism about the possibility of meaningful recovery for certain patients impacted by TBI.
Traumatic brain injury (TBI) is now widely viewed as a long-term health condition, as accumulating evidence indicates that its consequences can persist for extended periods, particularly in cases of moderate to severe injury. Although many patients with mild TBI experience recovery within a relatively short time, recent research suggests that symptoms in both children and adults may continue for a year or even longer. These observations highlight the importance of enhancing follow-up care and implementing long-term management approaches that are tailored to different age groups.
One emerging scope of interest in TBI recovery is the role of family involvement, particularly through interventions aimed at enhancing affective stimulation. Family-centered care, which places the family at the core of the patient's recovery process, has been identified as a critical component in improving outcomes for individuals with TBI.
Recent research emphasizes the essential role of family involvement in the rehabilitation process, particularly in providing emotional and affective support. Family-centered care (FCC) has emerged as a key model of care delivery, promoting collaboration between healthcare providers and family members to support patients holistically. FCC has been associated with improved recovery outcomes and may reduce healthcare costs by decreasing the need for prolonged hospital stays or frequent medical interventions. Within this framework, family-centered affective stimulation including structured emotional and psychosocial engagement by family members, has gained attention as an effective strategy to enhance recovery as well as functional outcomes in patients with traumatic brain injury (TBI).
It had been revealed by a systematic review and meta-analysis that it is more efficient to early stimulation family-centered sensory and affective than routine care or nurse-implemented sensory stimulation in terms of enhancing both the level of consciousness and cognitive functioning in comatose patients with traumatic brain injury. Furthermore, the review indicated that in terms of recovery outcomes promotion, multi-sensory stimulation turned out to be more efficient than single-modality stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Family-Centered Affective Stimulation (FCAS) | Experimental | Behavioral: Family-Centered Affective Stimulation (FCAS)The intervention phase involved the systematic implementation of Family-Centered Affective Stimulation (FCAS). Family members were guided to provide structured emotional and sensory stimulation, including verbal communication, familiar voices, emotional reassurance, and gentle touch, in accordance with the prescribed protocol. The intervention was administered for a specified duration and frequency, under continuous clinical supervision to ensure patient safety and adherence to the protocol. During the intervention period, patients were continuously monitored, and periodic assessments were conducted to evaluate their responses. Changes in level of consciousness, behavioral reactions, and physiological parameters were observed and documented at regular intervals. The research team closely supervised the sessions to ensure consistency and provided ongoing support to participating family members. Any adverse responses or deviations from the protocol were promptly recorded and addressed. |
| Control group: Standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- comprised adult patients admitted to the intensive care unit
- adults who were diagnosed with traumatic brain injury (TBI)
- the patients are ranging from mild to severe, with a Glasgow Coma Scale (GCS) score of 5-8
- the patients without significant co-existing medical or psychiatric conditions that could affect recovery.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Family-Centered Affective Stimulation (FCAS)Family members were guided to provide structured emotional and sensory stimulation, including verbal communication, familiar voices, emotional reassurance, and gentle touch, in accordance with the prescribed protocol. The intervention was administered for a specified duration and frequency, under continuous clinical supervision to ensure patient safety and adherence to the protocol. During the intervention period, patients were continuously monitored, and periodic assessments were conducted to evaluate their responses. Changes in level of consciousness, behavioral reactions, and physiological parameters were observed and documented at regular intervals. The research team closely supervised the sessions to ensure consistency and provided ongoing support to participating family members. Any adverse responses or deviations from the protocol were promptly recorded and addressed. | Behavioural | Intervention group: Family-Centered Affective Stimulation (FCAS) |
Primary outcome
Coma Recovery Assessment
Time frame: Two timepoints, : T0 at baseline and at T1 at 6 months
The Coma Recovery Assessment is a standardized tool designed to measure neurobehavioral function. The Coma Recovery Scale-Revised (CRS-R) is a reference standard for assessing neurobehavioral function and diagnosing disorders of consciousness. It is made up by six subscales: auditory, visual, motor, or motor/verbal, communication, and arousal. The items of CRS-R as well as rating scale categories were refined to enhance clinical utility, construct validity, and diagnostic accuracy. Each subscale follows a hierarchical scoring system, with higher scores indicating greater neurobehavioral function. The number of scoring categories differs across the subscales. For example, the communication subscale includes three response options (0, 1, and 2), while the motor subscale contains seven categories ranging from 0 to 6. Consequently, the total raw score of the CRS-R can vary between 0 and 23.
2 secondary outcomes
Modified Early Warning Score (MEWS)
Time frame: Two timepoints, : T0 at baseline and at T1 at 6 months
Full Outline of Unresponsiveness (FOUR) Score
Time frame: Two timepoints, : T0 at baseline and at T1 at 6 months
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 4 Jun 2026.
- Background25. Peterson AB, Thomas KE, Zhou H. Surveillance report of traumatic brain injury-related deaths by age group, sex, and mechanism of injury-United States, 2018 and 2019.
- Background: PubMed 40494742Tien HY, Su JS, Yu WY, Pan ML, Yang YC, Chiou YJ, Chen CY, Wu CK, Chen HM, Chen CY, Huei-Ming Ma M. Leveraging the Modified Early Warning Score (MEWS) in rapid response teams to predict and prevent ICU readmissions. J Formos Med Assoc. 2025 Jun 9:S0929-6646(25)00283-9. doi: 10.1016/j.jfma.2025.06.009. Online ahead of print.
- Background: PubMed 36303273Ahmed FR, Attia AK, Mansour H, Megahed M. Outcomes of family-centred auditory and tactile stimulation implementation on traumatic brain injured patients. Nurs Open. 2023 Mar;10(3):1601-1610. doi: 10.1002/nop2.1412. Epub 2022 Oct 27.
- Background: PubMed 36203763Adineh M, Elahi N, Molavynejad S, Jahani S, Savaie M. Impact of a sensory stimulation program conducted by family members on the consciousness and pain levels of ICU patients: A mixed method study. Front Med (Lausanne). 2022 Sep 20;9:931304. doi: 10.3389/fmed.2022.931304. eCollection 2022.
- Background: PubMed 35570725Weaver JA, Cogan AM, O'Brien KA, Hansen P, Giacino JT, Whyte J, Bender Pape T, van der Wees P, Mallinson T. Determining the Hierarchy of Coma Recovery Scale-Revised Rating Scale Categories and Alignment with Aspen Consensus Criteria for Patients with Brain Injury: A Rasch Analysis. J Neurotrauma. 2022 Oct;39(19-20):1417-1428. doi: 10.1089/neu.2022.0095. Epub 2022 Jun 16.
- Background13. Chandrasekharan S, Sreedharan J, Gopakumar A. Statistical issues in small and large sample: Need of optimum upper bound for the sample size. Int J Comput Theor Stat. 2019;6(2):108-118.
- Background11. Maciejewski ML. Quasi-experimental design. Biostat Epidemiol. 2020;4(1):38-47. doi:10.1080/24709360.2018.1477468.
- Background: PubMed 33485101Zuo J, Tao Y, Liu M, Feng L, Yang Y, Liao L. The effect of family-centered sensory and affective stimulation on comatose patients with traumatic brain injury: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103846. doi: 10.1016/j.ijnurstu.2020.103846. Epub 2020 Dec 7.
- Background: PubMed 30333789Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, Di H, Schnakers C. Do Sensory Stimulation Programs Have an Impact on Consciousness Recovery? Front Neurol. 2018 Oct 2;9:826. doi: 10.3389/fneur.2018.00826. eCollection 2018.
- Background: PubMed 37332244Carrier SL, Ponsford J, McKay A. Family experiences of supporting a relative with agitation during early recovery after traumatic brain injury. Neuropsychol Rehabil. 2024 May;34(4):510-534. doi: 10.1080/09602011.2023.2219064. Epub 2023 Jun 18.
- Background: PubMed 33318675Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14.
- Background2. Lewis CC, Lobo D. Effectiveness of the multi-modal sensory stimulation on the level of consciousness among unconscious patients. J Health Allied Sci NU. 2026;16:26. doi:10.25259/JHS-2024-3-5-R4-(1280).
- Individual participant dataSharing planned: Yes. The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
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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.
Walid Elsayed Hemaida, PhD study chair
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Centered Affective Stimulation (FCAS) in people with Patients With Traumatic Brain Injury and Coma, Traumatic, 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 1 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 4 Jun 2026. 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?
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?
Coma Recovery Assessment (time frame: Two timepoints, : T0 at baseline and at T1 at 6 months). 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 NCT07537023, which also lists 13 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 4 Jun 2026.