Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Aneurysmal Subarachnoid Hemorrhage

NCT06648187 | Not Yet Recruiting

• 1 other identifier: 202405012RINB
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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, 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).

Conditions

Subarachnoid Aneurysm Hemorrhage

Keywords

Aneurysmal Subarachnoid Hemorrhage; Motor-Cognitive Integrative Training; Cognition; Early mobilization

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)

• Motor impairment

  All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)

• Muscle strength

  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

  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

  All tested at T0(baseline), T1(discharge from ICU, an average of 2 weeks), T2(discharge from hospital, an average of 4weeks)

Study Arms (1)

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.

Other: Early motor-cognitive integrative training (e-MCIT)

Interventions

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.

Early motor-cognitive integrative training (e-MCIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (5)

• 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.

  PMID: 34840972 BACKGROUND

• Morello 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.

  PMID: 38262007 BACKGROUND

• Nussbaum 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.

  PMID: 33345644 BACKGROUND

• Geraghty 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.

  PMID: 32807442 BACKGROUND

• Karic 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.

  PMID: 27058204 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Po-Min Hsu

CONTACT

+886-932-032-382; min032382@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share