Clinical Trials Logo

Clinical Trial Summary

Fatigue is among the most frequently reported sequelae in stroke survivors. For a specific stroke diagnosis, aneurysmal subarachnoid hemorrhage (aSAH), fatigue, in general, is reported to be present in 30 to 90% of the patients. It is the mental fatigue component that significantly contributes to difficulties that patients with aSAH face when returning to normal life. However, there is substantial variation in the reported incidence of mental fatigue (25%-60%), which may be attributed to several methodological factors, such as differences in the follow-up periods and instruments used. Consequently, a complete understanding of how mental fatigue influences long-term recovery remains elusive. This research project will contribute to new and important knowledge in long-term effects after SAH when it comes to mental fatigue. In this study patients surviving an SAH will be assessed for mental fatigue at 5 years after the insult. The patients have previously been assessed at 1 and 3 years. All patients have been treated at Sahlgrenska University Hospital during the acute phase after SAH. Follow-up is performed after 5 years after aSAH through a structured telephone interview, where patients are scored using the Glasgow Outcome Scale-Extended (GOSE) Additionally, the patients receive a self-assessment questionnaire, the Mental Fatigue Scale, Patients are reminded to return the questionnaires at three times. This study aims to determine the long-term prevalence, severity, and dynamics of mental fatigue at 1, 3, and 5 years after an aSAH. The study also aims to identify whether demographic characteristics and secondary complications or diagnoses after aSAH can be associated with an increased risk of developing mental fatigue or unfavourable outcome.


Clinical Trial Description

In this study patients surviving an SAH will be assessed for mental fatigue at 5 years after the insult. The patients have previously been assessed at 1 and 3 years. All patients have been treated at Sahlgrenska University Hospital during the acute phase after SAH. Follow-up is performed after 5 years after aSAH through a structured telephone interview, where patients are scored using the Glasgow Outcome Scale-Extended (GOSE) Additionally, the patients receive a self-assessment questionnaire, the Mental Fatigue Scale, Patients are reminded to return the questionnaires at three times. Primary outcome measure: The Mental Fatigue Scale (MFS)score The MFS is a multidimensional self-reporting questionnaire developed for assessing different aspects of mental fatigue in patients with brain injuries. It comprises 15 items regarding fatigue, including lack of initiative; mental recovery; concentration difficulties; memory problems; slowness of thinking; sensitivity to stress; increased mental fatigue, increased tendency to become emotional; irritability; sensitivity to light and noise; and decreased or increased sleep duration. Each item has four response options ranging from 0 (normal function) to 3 (maximal problems); further, one can select response points in between (i.e., 0,5, 1,5, and 2,5), which yields a total of seven options. Items 1-14 are used to calculate the total score, with a maximum score of 42. We did not include item 15, which assesses 24-h variations, in the total score, but it can be used in clinical practice. An MFS score ≥ 10.5 indicates mental fatigue. A higher MFS score indicates more severe problems. This study explores the presence, severity and dynamics of mental fatigue. The Glasgow Outcome Scale-Extended (GOSE) The GOSE evaluates the patient's functional outcome and level of independence in eight different domains of daily living, including physical, cognitive, emotional, and social functioning. It was developed to classify patients after a traumatic or nontraumatic brain injury, allowing for comparisons of outcomes between patients. The scale ranges from death (1 point) to good recovery (8 points), with higher scores indicating better outcomes and higher levels of independence. A GOSE score of 8 indicates full recovery with only minor symptoms that do not affect activities of daily living (ADL). A GOSE score of ≥ 5 indicates that patients can independently manage their ADL and is used in studies to describe a favorable outcome 5,28. Secondary Outcome Measures are the association between mental fatigue and GOSE, demographics, complications during the acute phase and loss of conscious at ictus. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06239142
Study type Observational
Source Sahlgrenska University Hospital, Sweden
Contact
Status Active, not recruiting
Phase
Start date May 2015
Completion date June 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06032533 - Remote Ischemic Conditioning in Aneurysmal SAH N/A
Completed NCT05131295 - Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage. Phase 3
Recruiting NCT04583163 - Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
Recruiting NCT06006975 - Early Warning of Delayed Cerebral Ischemia
Terminated NCT02893826 - Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH Phase 1
Unknown status NCT01567449 - Risk Factors for Aneurysm Rebleeding N/A
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Not yet recruiting NCT04512859 - Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage N/A
Recruiting NCT05103566 - Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage N/A
Not yet recruiting NCT04696523 - Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage Phase 2
Completed NCT04415736 - Artificial Intelligence in Subarachnoid Hemorrhage
Recruiting NCT05925478 - Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage Early Phase 1
Recruiting NCT04649398 - Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration
Recruiting NCT02995928 - Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage N/A
Recruiting NCT04945603 - Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Completed NCT03318783 - Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial Phase 1/Phase 2
Terminated NCT05686265 - Cerebral Nitrosative/Oxidative Stress in Aneurysmal Subarachnoid Haemorrhage
Not yet recruiting NCT06057155 - Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle
Not yet recruiting NCT06359782 - Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) Phase 2
Completed NCT03115905 - A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage in China