Subarachnoid Aneurysm HemorrhageNCT06648187
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Aneurysmal Subarachnoid Hemorrhage
A study testing Early motor-cognitive integrative training (e-MCIT) in people with Subarachnoid Aneurysm Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Despite its lower incidence rate within the stroke population and tendency to affect younger individuals, SAH carries the highest risk of PSCI. The neural mechanisms underlying these cognitive deficits remain poorly understood, but potential factors include treatment approaches, underlying disease pathophysiology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Aneurysm Hemorrhage
- What is being tested?
- Early motor-cognitive integrative training (e-MCIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography.
- Onset of stroke occurring in the acute phase, specifically 2-7 days after medical intervention.
- Participants must be over 18 years old.
- WFNS: 1-3.
- Able to stand without support above 30 seconds.
- Montreal Cognitive Assessment (MoCA)<26.
Who cannot join
- unstable vital sign (e.g., heart rate (HR): 40- 100bpm, mean arterial pressure (MAP)> 80mmHg, respiratory rate (RR): 12-20, oxygen saturation (SpO2) > 95%, intracranial pressure (ICP) < 20mmHg and cerebral perfusion pressure (CPP) > 70mmHg)
- patients evaluated as unsuitable by their attending physician
- those with other neurological diseases that might interfere with the experiment
- with less than 12 years of education
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 100
About this study
Official title: The Efficacy of Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
Despite its lower incidence rate within the stroke population and tendency to affect younger individuals, SAH carries the highest risk of PSCI. The neural mechanisms underlying these cognitive deficits remain poorly understood, but potential factors include treatment approaches, underlying disease pathophysiology, post-disease complications, or alterations in neural connectivity. Previous literature indicates that cognitive deficits in SAH primarily manifest in areas such as visuospatial skill, verbal memory language abilities (including verbal comprehension, verbal fluency, abstract language), executive function (working memory) and attention. These impairments significantly impact patients' ability to perform ADL independently and return to work, despite motor function recovery. This pilot study tests the feasibility, logistics, and methodology of the research project, as well as to identify any potential problems or challenges that may arise. In the future, the investigators plan to examine the impact of early intervention with MCIT (e-MCIT) on cognitive function, motor recovery, functional abilities, and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment. The hypothesis of this study is that there is feasibility and safety in early intervention with MCIT (e-MCIT) in aSAH patients. Otherwise, e-MCIT will result in significant improvements in cognitive function, motor recovery, functional abilities, and ADL among SAH patients upon discharge from the ICU and the post-intervention assessment (in future work will identify by comparing with early mobilization group only).
Read the detailed description
Background and literature review: Spontaneous subarachnoid hemorrhage (SAH), often resulting from intracerebral aneurysm rupture is a relatively uncommon but impactful form of stroke predominantly affecting middle-aged individuals. Aneurysmal SAH (aSAH) presents a high risk of post-stroke cognitive impairment (PSCI) compared to other stroke types, with an occurrence rate ranging from 26% to 43%. Cognitive impairments, particularly in executive function, attention, memory, and language abilities, are prevalent among aSAH survivors, with notable differences observed in cognitive outcomes based on medical interventions such as clipping or coiling. Additionally, cerebral changes following aSAH, including delayed onset cerebral infraction, white matter hyperintensities and focal encephalomalacia, contribute to cognitive deficits. In clinical settings, patients with aSAH often demonstrate notable improvements in motor function recovery, however, cognitive issues, such as executive function and complex attention, are closely linked to patients' inability to perform the activities of daily living (ADL) independently and return to work, even after disease recovery. While physical therapy interventions, including early mobilization, show promise in enhancing functional outcomes, there is a dearth of research specifically addressing cognitive rehabilitation in aSAH patients.
Integration of motor-cognitive training approaches, such as motor-cognitive integrative training (MCIT), may hold potential for improving cognitive and motor recovery in SAH patients, akin to their application in other neurological disorders like Parkinson's disease and stroke. Understanding the intricate relationship between cognitive deficits and functional outcomes is crucial for developing targeted rehabilitation strategies to improve the quality of life for aSAH survivors.
Purpose: This pilot study tests the feasibility, logistics, and methodology of the research project, as well as to identify any potential problems or challenges that may arise. In the future, the investigators plan to examine the impact of early intervention with MCIT (e-MCIT) on cognitive function, motor recovery, functional abilities, and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment.
Study design: This is a pilot study to testify the feasibility, logistics, and methodology of evaluation and early motor-cognitive integrative training (e- MCIT) on cognitive function, motor recovery, functional ability and abilities in ADL in patients with aSAH in acute phase. The intervention commences during the acute setting in the ICU period and extends through the subacute phase in the hospital's general ward. Evaluation will be conducted at three assessment time points including baseline assessment (following initial medical intervention), assessment at the time of discharge from the intensive care center (ICU), and discharge from the hospital. After recruiting in this study, participants all receive the intervention of e-MCIT. If the subjects can complete the tasks, the results and completion times will be recorded. If the tasks cannot be completed, this situation and its probability will be documented as well. Due to the large number of measurement items in this study, it is expected to take a longer time. Breaks will be taken as needed according to each subject's tolerance. If the tasks cannot be completed in one session, they will be carried over to the next day. Our future study will be well-designed according to the result from this study.
Method: Patients with aSAH will be recruited, which Inclusion criteria for enrolment are as follows: (1) Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography. (2) Onset of stroke occurring in the acute phase, specifically 2-7 days after medical intervention. (3) Participants must be over 18 years old. (4) WFNS: 1-3. (5) Able to stand without support above 30 seconds. (6) Montreal Cognitive Assessment (MoCA)<26. Patients who present unstable vital sign (e.g., heart rate (HR): 40-100bpm, mean arterial pressure (MAP)> 80mmHg, respiratory rate (RR): 12-20, oxygen saturation (SpO2) > 95%, intracranial pressure (ICP) < 20mmHg and cerebral perfusion pressure (CPP) > 70mmHg) according to the criteria in previous study or evaluated as unsuitable by their attending physician will be excluded. Participants who are with other neurological disease might interfere the experiment and their education years less than 12 years will be excluded in this study. The e-MCIT consists of early mobilization and early cognitive training. Intervention will be 30 minutes per session, 4-5 sessions per week until discharging from the hospital. Outcome measurements includes side-effect events record, Montreal Cognitive Assessment (MoCA), Trail Making Test part A(TMT- A), Trail Making Test part B(TMT-B), Stroop color and word test (SCWT), forward and reverse digit span (DS) test, Go and no-go (GNG) test, Semantic Verbal Fluency test (SVFT), Fugl-Meyer Assessment for upper extremity (FMA- UE) and lower extremity (FMA-LE), Medical Research Council (MRC), Functional ambulatory category (FAC), kinematics performance in single and dual task ability, brain activity by functional Near-Infrared Spectroscopy (fNIRS) during all cognition assessment and in single and dual task, Functional independence measure (FIM), Modified Rankin Scale (mRS), Perme ICU mobility score, and National Institutes of Health Stroke Scale (NIHSS) . Statistical analysis was conducted using SPSS version 26.0. Categorical variables in the descriptive data of the participants were presented as numbers and percentages, while continuous variables were expressed as mean ± standard deviation. Nominal variables would be analyzed by X2 test. Wilcoxon Signed-Rank Test will be used to test the differences between pre-test and post-intervention time points due to small sample size. A two-tailed significance level (α) was set at 0.05. Thus, p< 0.05 revealed significant difference.
- Conditions
- Subarachnoid Aneurysm Hemorrhage
- Being tested
- Early motor-cognitive integrative training (e-MCIT)
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, Motor-Cognitive Integrative Training, Cognition, Early mobilization
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early motor-cognitive integrative training (e-MCIT)Other
Early motor-cognitive integrative training (e-MCIT) is an approach where motor and cognitive training are conducted simultaneously. The intervention consists of 30-minute sessions, conducted 4-5 times per week, until discharging from the hospital. Both motor and cognitive training have five stages each, and their progression is independent, meaning that during training, a participant might be in the fourth stage of motor training and the second stage of cognitive training. According to hospital's policy, occupational therapy and speech therapy will be provided in schedule if needed. Motor training is derived from a previous protocol of early mobilization intervention applied to a population with SAH, which based on the ICU Mobility Scale. The activities of cognitive training target areas such as attention, orientation, language ability, memory, calculation, judgment, working memory, executive function, and daily living functions.
| Study group | Role | What they receive |
|---|---|---|
| Early motor-cognitive integrative training (e-MCIT) | Experimental | Evaluation will be conducted at three assessment time points including baseline assessment (following initial medical intervention), assessment at the time of discharge from the intensive care center (an average of 2 weeks), and discharge from the hospital (an average of 4 weeks). After recruiting in this study, participants all receive the intervention of e-MCIT. Receives: Other: Early motor-cognitive integrative training (e-MCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition
Global cognitive function will be measured by Montreal Cognitive Assessment (MoCA). Sum of score ranges from 0 to 30. There are eight subdivision of cognition category in this test, including visuospatial/ executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Many studies assess global cognitive function in SAH patient by MoCA, which showed less ceiling or floor effect.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Executive function
Executive function will be measured by three tests: Trail Making Test part A(TMT-A), Trail Making Test part B(TMT-B) and Stroop color and word test (SCWT), and scoring is based on time taken to complete the test with lower scores being better. Accuracy rate will be recorded as well.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Working memory
Working memory will be measured by digit span (DS) test, which also usually represents subject's ability of verbal memory. Indicator for DS is the sum of the total scores for forward and reverse DS, with a score range of 0-30 points. A higher score indicates better performance.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Attention
Attention ability will be measure by Go and no-go (GNG) test, which also represents subject's ability of set shifting, processing speed, and selective inhibition or also called inhibitory control.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Language ability
In category of language ability, verbal fluency will be measured by Semantic Verbal Fluency test (SVFT). The session consisted of three trials. Trials consisted of three different characters with the same pronunciation (20s / a Chinese character). The stimulation task was randomized to every subjects. Between three trails, there are 30 seconds in resting periods. Score 1 point for each correct answer, with total score of nine. Every correct and incorrect instance will be recorded. Accuracy rate (AR) will be calculated as the same method in GNG test. A higher accuracy rate also indicates better performance.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Secondary outcomes (7)
Brain activity
Functional Near-Infrared Spectroscopy (fNIRS), which is a non-invasive neuro-imaging technique, will be used to detect the cerebral hemodynamics. The fNIRS data acquire via multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NYC, USA). Exports and receives dual-wavelength near-infrared signals are 760 and 850 nm. Data collection includes measurement changes in oxyhemoglobin [HbO], de-oxyhemoglobin [HbR] and the difference between HbO and HbR. The probe will not be placed above the surgical wound site. In cognition assessments: TMT-A\& TMT-B, SCWT, DS, and GNG test, Optodes are configured to target both the bilateral prefrontal cortex (PFC) and the posterior parietal cortex (PPC). The setup involves 16 LED light sources and 16 detectors (16x16), resulting in 39 channels for the collection of hemodynamic data.
Measured: T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Motor impairment
Motor impairment after stroke was measured by Fugl-Meyer Assessment for upper extremity (FMA-UE) and lower extremity (FMA-LE). In FMA-UE, part A to D, including subtests of upper extremity, wrist, hand, and coordination/ speed will be used only. The score ranges from 0 to 66. In FMA-LE, part E to F, including subtests of lower extremity, and coordination/ speed will be used only. The score ranges from 0 to 34. Both scores with higher score indicates better motor function
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Muscle strength
Key muscles strength was measured by Medical Research Council (MRC) scale. The scoring system is the same with manual muscle testing (MMT), with grade from 0 to 5. Total of score is 60, with higher scores indicating better strength.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Ability of ambulation
Functional ambulatory category (FAC) would be used to assess the subject's ability of ambulation. FAC consists of six level, ranging from 0 to 5. The higher level indicates better ability of ambulation.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional Independence in ADL
Functional independence measure (FIM) would be used to evaluate subject's ability of ADL. FIM consists of motor items and cognitive items.
Motor items include subtest of self-care, sphincter control, mobility/ transfer, and locomotion. Cognitive items include subtest of communication and social cognition. The higher score indicates better independent ability. Scoring levels range from 1 to 7, thus, sum of score in FIM ranges from 18 to 126. The higher score indicates better independent ability.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional ability
Modified Rankin Scale (mRS) would be used to assess the degree of disability or dependence in ADL. There are seven levels in mRS, with ranging from 0 to 6. Among this scale, the higher scale indicates less function ability.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional status in ICU
Perme ICU mobility score will be assessed at first time evaluation in ICU and discharge from ICU, which including mental status, potential mobility barriers, functional strength and functional ability. The higher score indicates better function status.
Measured: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024
- Primary completion25 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Aneurysm HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648187
- Sponsor's protocol ID
- 202405012RINB
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun R, Li X, Zhu Z, Li T, Li W, Huang P, Gong W. Effects of Combined Cognitive and Exercise Interventions on Poststroke Cognitive Function: A Systematic Review and Meta-Analysis. Biomed Res Int. 2021 Nov 17;2021:4558279. doi: 10.1155/2021/4558279. eCollection 2021.
PubMed 34840972Morello A, Spinello A, Staartjes VE, Bue EL, Garbossa D, Germans MR, Regli L, Serra C. Early versus delayed mobilization after aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of efficacy and safety. Neurosurg Focus. 2023 Dec;55(6):E11. doi: 10.3171/2023.9.FOCUS23548.
PubMed 38262007Nussbaum ES, Mikoff N, Paranjape GS. Cognitive deficits among patients surviving aneurysmal subarachnoid hemorrhage. A contemporary systematic review. Br J Neurosurg. 2021 Aug;35(4):384-401. doi: 10.1080/02688697.2020.1859462. Epub 2020 Dec 21.
PubMed 33345644Geraghty JR, Lara-Angulo MN, Spegar M, Reeh J, Testai FD. Severe cognitive impairment in aneurysmal subarachnoid hemorrhage: Predictors and relationship to functional outcome. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105027. doi: 10.1016/j.jstrokecerebrovasdis.2020.105027. Epub 2020 Jun 20.
PubMed 32807442Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.
PubMed 27058204
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
- ClinicalTrials.gov ID
- NCT06648187
- Acronym / sponsor ID
- 202405012RINB
- Conditions
- Subarachnoid Aneurysm Hemorrhage
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, Motor-Cognitive Integrative Training, Cognition, Early mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Oct 2024 (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.
Despite its lower incidence rate within the stroke population and tendency to affect younger individuals, SAH carries the highest risk of PSCI. The neural mechanisms underlying these cognitive deficits remain poorly understood, but potential factors include treatment approaches, underlying disease pathophysiology, post-disease complications, or alterations in neural connectivity. Previous literature indicates that cognitive deficits in SAH primarily manifest in areas such as visuospatial skill, verbal memory language abilities (including verbal comprehension, verbal fluency, abstract language), executive function (working memory) and attention. These impairments significantly impact patients' ability to perform ADL independently and return to work, despite motor function recovery. This pilot study tests the feasibility, logistics, and methodology of the research project, as well as to identify any potential problems or challenges that may arise. In the future, the investigators plan to examine the impact of early intervention with MCIT (e-MCIT) on cognitive function, motor recovery, functional abilities, and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment. The hypothesis of this study is that there is feasibility and safety in early intervention with MCIT (e-MCIT) in aSAH patients. Otherwise, e-MCIT will result in significant improvements in cognitive function, motor recovery, functional abilities, and ADL among SAH patients upon discharge from the ICU and the post-intervention assessment (in future work will identify by comparing with early mobilization group only).
Detailed description
Background and literature review: Spontaneous subarachnoid hemorrhage (SAH), often resulting from intracerebral aneurysm rupture is a relatively uncommon but impactful form of stroke predominantly affecting middle-aged individuals. Aneurysmal SAH (aSAH) presents a high risk of post-stroke cognitive impairment (PSCI) compared to other stroke types, with an occurrence rate ranging from 26% to 43%. Cognitive impairments, particularly in executive function, attention, memory, and language abilities, are prevalent among aSAH survivors, with notable differences observed in cognitive outcomes based on medical interventions such as clipping or coiling. Additionally, cerebral changes following aSAH, including delayed onset cerebral infraction, white matter hyperintensities and focal encephalomalacia, contribute to cognitive deficits. In clinical settings, patients with aSAH often demonstrate notable improvements in motor function recovery, however, cognitive issues, such as executive function and complex attention, are closely linked to patients' inability to perform the activities of daily living (ADL) independently and return to work, even after disease recovery. While physical therapy interventions, including early mobilization, show promise in enhancing functional outcomes, there is a dearth of research specifically addressing cognitive rehabilitation in aSAH patients.
Integration of motor-cognitive training approaches, such as motor-cognitive integrative training (MCIT), may hold potential for improving cognitive and motor recovery in SAH patients, akin to their application in other neurological disorders like Parkinson's disease and stroke. Understanding the intricate relationship between cognitive deficits and functional outcomes is crucial for developing targeted rehabilitation strategies to improve the quality of life for aSAH survivors.
Purpose: This pilot study tests the feasibility, logistics, and methodology of the research project, as well as to identify any potential problems or challenges that may arise. In the future, the investigators plan to examine the impact of early intervention with MCIT (e-MCIT) on cognitive function, motor recovery, functional abilities, and ADL in acute SAH patients upon discharge from the ICU and during the post-intervention assessment.
Study design: This is a pilot study to testify the feasibility, logistics, and methodology of evaluation and early motor-cognitive integrative training (e- MCIT) on cognitive function, motor recovery, functional ability and abilities in ADL in patients with aSAH in acute phase. The intervention commences during the acute setting in the ICU period and extends through the subacute phase in the hospital's general ward. Evaluation will be conducted at three assessment time points including baseline assessment (following initial medical intervention), assessment at the time of discharge from the intensive care center (ICU), and discharge from the hospital. After recruiting in this study, participants all receive the intervention of e-MCIT. If the subjects can complete the tasks, the results and completion times will be recorded. If the tasks cannot be completed, this situation and its probability will be documented as well. Due to the large number of measurement items in this study, it is expected to take a longer time. Breaks will be taken as needed according to each subject's tolerance. If the tasks cannot be completed in one session, they will be carried over to the next day. Our future study will be well-designed according to the result from this study.
Method: Patients with aSAH will be recruited, which Inclusion criteria for enrolment are as follows: (1) Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography. (2) Onset of stroke occurring in the acute phase, specifically 2-7 days after medical intervention. (3) Participants must be over 18 years old. (4) WFNS: 1-3. (5) Able to stand without support above 30 seconds. (6) Montreal Cognitive Assessment (MoCA)<26. Patients who present unstable vital sign (e.g., heart rate (HR): 40-100bpm, mean arterial pressure (MAP)> 80mmHg, respiratory rate (RR): 12-20, oxygen saturation (SpO2) > 95%, intracranial pressure (ICP) < 20mmHg and cerebral perfusion pressure (CPP) > 70mmHg) according to the criteria in previous study or evaluated as unsuitable by their attending physician will be excluded. Participants who are with other neurological disease might interfere the experiment and their education years less than 12 years will be excluded in this study. The e-MCIT consists of early mobilization and early cognitive training. Intervention will be 30 minutes per session, 4-5 sessions per week until discharging from the hospital. Outcome measurements includes side-effect events record, Montreal Cognitive Assessment (MoCA), Trail Making Test part A(TMT- A), Trail Making Test part B(TMT-B), Stroop color and word test (SCWT), forward and reverse digit span (DS) test, Go and no-go (GNG) test, Semantic Verbal Fluency test (SVFT), Fugl-Meyer Assessment for upper extremity (FMA- UE) and lower extremity (FMA-LE), Medical Research Council (MRC), Functional ambulatory category (FAC), kinematics performance in single and dual task ability, brain activity by functional Near-Infrared Spectroscopy (fNIRS) during all cognition assessment and in single and dual task, Functional independence measure (FIM), Modified Rankin Scale (mRS), Perme ICU mobility score, and National Institutes of Health Stroke Scale (NIHSS) . Statistical analysis was conducted using SPSS version 26.0. Categorical variables in the descriptive data of the participants were presented as numbers and percentages, while continuous variables were expressed as mean ± standard deviation. Nominal variables would be analyzed by X2 test. Wilcoxon Signed-Rank Test will be used to test the differences between pre-test and post-intervention time points due to small sample size. A two-tailed significance level (α) was set at 0.05. Thus, p< 0.05 revealed significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early motor-cognitive integrative training (e-MCIT) | Experimental | Other: Early motor-cognitive integrative training (e-MCIT)Evaluation will be conducted at three assessment time points including baseline assessment (following initial medical intervention), assessment at the time of discharge from the intensive care center (an average of 2 weeks), and discharge from the hospital (an average of 4 weeks). After recruiting in this study, participants all receive the intervention of e-MCIT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of spontaneous SAH resulting from aneurysm rupture confirmed by either CT scan or angiography.
- Onset of stroke occurring in the acute phase, specifically 2-7 days after medical intervention.
- Participants must be over 18 years old.
- WFNS: 1-3.
- Able to stand without support above 30 seconds.
Key exclusion criteria (4 listed)
- unstable vital sign (e.g., heart rate (HR): 40- 100bpm, mean arterial pressure (MAP)> 80mmHg, respiratory rate (RR): 12-20, oxygen saturation (SpO2) > 95%, intracranial pressure (ICP) < 20mmHg and cerebral perfusion pressure (CPP) > 70mmHg)
- patients evaluated as unsuitable by their attending physician
- those with other neurological diseases that might interfere with the experiment
- with less than 12 years of education
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 |
|---|---|---|
| Early motor-cognitive integrative training (e-MCIT)Early motor-cognitive integrative training (e-MCIT) is an approach where motor and cognitive training are conducted simultaneously. The intervention consists of 30-minute sessions, conducted 4-5 times per week, until discharging from the hospital. Both motor and cognitive training have five stages each, and their progression is independent, meaning that during training, a participant might be in the fourth stage of motor training and the second stage of cognitive training. According to hospital's policy, occupational therapy and speech therapy will be provided in schedule if needed. Motor training is derived from a previous protocol of early mobilization intervention applied to a population with SAH, which based on the ICU Mobility Scale. The activities of cognitive training target areas such as attention, orientation, language ability, memory, calculation, judgment, working memory, executive function, and daily living functions. | Other | Early motor-cognitive integrative training (e-MCIT) |
Primary outcome
Global cognition
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Global cognitive function will be measured by Montreal Cognitive Assessment (MoCA). Sum of score ranges from 0 to 30. There are eight subdivision of cognition category in this test, including visuospatial/ executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Many studies assess global cognitive function in SAH patient by MoCA, which showed less ceiling or floor effect.
Executive function
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Executive function will be measured by three tests: Trail Making Test part A(TMT-A), Trail Making Test part B(TMT-B) and Stroop color and word test (SCWT), and scoring is based on time taken to complete the test with lower scores being better. Accuracy rate will be recorded as well.
Working memory
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Working memory will be measured by digit span (DS) test, which also usually represents subject's ability of verbal memory. Indicator for DS is the sum of the total scores for forward and reverse DS, with a score range of 0-30 points. A higher score indicates better performance.
Attention
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Attention ability will be measure by Go and no-go (GNG) test, which also represents subject's ability of set shifting, processing speed, and selective inhibition or also called inhibitory control.
Language ability
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
In category of language ability, verbal fluency will be measured by Semantic Verbal Fluency test (SVFT). The session consisted of three trials. Trials consisted of three different characters with the same pronunciation (20s / a Chinese character). The stimulation task was randomized to every subjects. Between three trails, there are 30 seconds in resting periods. Score 1 point for each correct answer, with total score of nine. Every correct and incorrect instance will be recorded. Accuracy rate (AR) will be calculated as the same method in GNG test. A higher accuracy rate also indicates better performance.
7 secondary outcomes
Brain activity
Time frame: T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Motor impairment
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Muscle strength
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Ability of ambulation
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional Independence in ADL
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional ability
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)
Functional status in ICU
Time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks)
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 11 May 2026.
- Background: PubMed 34840972Sun R, Li X, Zhu Z, Li T, Li W, Huang P, Gong W. Effects of Combined Cognitive and Exercise Interventions on Poststroke Cognitive Function: A Systematic Review and Meta-Analysis. Biomed Res Int. 2021 Nov 17;2021:4558279. doi: 10.1155/2021/4558279. eCollection 2021.
- Background: PubMed 38262007Morello A, Spinello A, Staartjes VE, Bue EL, Garbossa D, Germans MR, Regli L, Serra C. Early versus delayed mobilization after aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of efficacy and safety. Neurosurg Focus. 2023 Dec;55(6):E11. doi: 10.3171/2023.9.FOCUS23548.
- Background: PubMed 33345644Nussbaum ES, Mikoff N, Paranjape GS. Cognitive deficits among patients surviving aneurysmal subarachnoid hemorrhage. A contemporary systematic review. Br J Neurosurg. 2021 Aug;35(4):384-401. doi: 10.1080/02688697.2020.1859462. Epub 2020 Dec 21.
- Background: PubMed 32807442Geraghty JR, Lara-Angulo MN, Spegar M, Reeh J, Testai FD. Severe cognitive impairment in aneurysmal subarachnoid hemorrhage: Predictors and relationship to functional outcome. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105027. doi: 10.1016/j.jstrokecerebrovasdis.2020.105027. Epub 2020 Jun 20.
- Background: PubMed 27058204Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.
- Individual participant dataSharing planned: No
Related trials for Subarachnoid Aneurysm Hemorrhage
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
Active, not recruitingObservational study
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Not yet recruiting
Surveillance Versus Treatment of Unruptured Intracranial Aneurysms of Fortuitous Discovery
Unruptured Intracranial Aneurysm, Intracranial Aneurysm
Not yet recruitingPhase 3
The Efficacy and Safety of Tirofiban Enhanced Antiplatelet Therapy in the Treatment of Ruptured Intracranial Aneurysms With Stent
Ruptured Intracranial Aneurysms, Subarachnoid Hemorrhage, Aneurysmal
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 Early motor-cognitive integrative training (e-MCIT) in people with Subarachnoid Aneurysm Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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 11 May 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 Taiwan. 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?
Global cognition (time frame: All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)). The study lists 5 primary outcomes in all. 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 NCT06648187, which also lists 5 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 11 May 2026.