Cognitive Impairment and Fatigue After Mild to Moderate COVID-19

NCT06042530 | Unknown

• 1 other identifier: 2021-03907_Cognition COVID-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the project is to map fatigue, cognitive and visual dysfunctions and possible underlying pathophysiological mechanisms in persons with long-term symptoms after a mild to moderate COVID-19 infection. Secondary goals are to study whether covarying factors such as depression and sleep disorders contribute to the results.

Conditions

Post COVID-19 Condition; Cognitive Impairment; Fatigue, Mental

Keywords

cognition; fatigue; COVID-19; neuropsychology; biomarkers; vision; imaging

Outcome Measures

Primary Outcomes (13)

• Fatigability from Wechsler Adult Intelligence Scale (WAIS)-IV Coding Test

  The subject must fill in the blank spaces with the symbol which is paired to the number for 120 seconds. Cognitive fatigue is assessed by subtracting the number of digits produced in the first 30 seconds from the number of digits produced in the last 30 seconds during the full 120-second period. A non-ascending score (\< 0) is considered an indicator of cognitive fatigue. Both the total value in the difference between the production between 0-30 seconds and 91-120 seconds are measured, and a dichotomized variable (non-ascending value) will be used.

  baseline

• Buschke selective reminding test (BSRT)

  The BSRT measure verbal learning and long-term memory. The subject hears a list of 12 unrelated words and immediately after that have to recall as many of these 12 words as possible. On each subsequent trial, the subject only hears the words that the subject did not recall on the immediately preceding trial. The test proceed in this manner until the subject can correctly recall all 12 words on two consecutive trials, or until 12 trials have been completed. Through assessing the recall of items that are not presented on a given trial, this test is believed to distinguish between retrieval from long-term storage (LTS) and short-term recall (STR). Consistent recalled words (CLTS) are thought to represent executive aspects of the learning process. After the learning phase, the subject is asked to free recall the words after a 30-minute delay. A cued recall and a multiple-choice condition are also included in the test.

  baseline

• Ruff 2&7

  Ruff 2 \& 7 measures sustained and selective attention as a continuous performance test during 5 minutes. The subject has to identify and cancel the target digits (2 and 7) among distractors; either letters (automatic sustained attention) or numbers (controlled selective attention), in random order. Both accuracy and speed are measured. Higher scores mean better performance. Performance is evaluated according to the test manual.

  baseline

• The Delis-Kaplan Executive Function System (D-KEFS) Color-Word Test

  Inhibition of over-learned verbal responses. The test has four conditions: 1) naming colors (red, blue or green, 2) reading color words printed in black, 3) naming the color of the color words red, blue or green write in a different color than what is written, which means inhibition of an over-learned function of reading the word; 4) repeatedly switching between naming colors and reading out the printed words as quickly as possible, while at the same time the person needs to keep track of clues that indicate rule change. Contrast scores are used to examine the performance of the more complex tasks 3 and 4 and the basic tasks 1 and 2. The faster the time, the better

  baseline

• Fatigability on e-prime vigilance task in the fMRI scanner

  The participants are instructed to push a button as quick as they can when a set of four zeroes appears in a red rectangle and do nothing if other numbers appear. After each response visual feedback of the reaction time is displayed. If the participant reacts at a false stimulus or if the response time of more than 1 sec. the feedback "false answer" or "no answer" is displayed respectively. The stimuli are presented at random intervals.

  baseline

• Task-based fMRI

  Cerebral perfusion changes during reaction time paradigm.

  baseline

• Resting-state fMRI

  Changes in functional connectivity after performance of a reaction time paradigm.

  baseline

• Developmental Eye Movement Test

  Saccadic eye movements are assessed with the Developmental Eye Movement Test. In the first step, the subject read 40 one-digit numbers arranged in two columns. Time duration and reading errors are measured. This is repeated with a new set of numbers where the subject read 80 numbers distributed over 16 horizontal lines. There are 5 irregularly spaced numbers per line, intended to mimic the way the eyes make saccadic movements during reading. For at ratio the total time duration for reading numbers horizontally is divided by the total time for reading numbers vertically.

  baseline

• Visual Motion Sensitivity

  Sensitivity to movement in the environment was assessed according to the Visual Motion Sensitivity Clinical Test Protocol. The subject is asked to stand and gaze straight ahead at a fixation mark on the wall at eye level at 4 m distance. An Opto Kinetic Nystagmus drum is held at 25 cm from the face. The drum is rotated at slow-medium velocity while the subject is asked to grade symptoms on a scale of 0-10, where zero means no bother at all and 10 a strong effect of nauseous or somatic or visual sensation.

  baseline

• Biomarkers

  S100B, Astrocyte-derived Extracellular Vesicles (EV) and High Mobility Group Box 1 (Hmbg1). Exploratory targeted analyses using panels of cytokines \& chemokines and neuroinflammation will also be used.

  baseline

• Symptom questionnaire

  The subject rates 32 different cognitive, emotional and physical symptoms where 0 represents have not had this symptom at all, 1 = have had the symptom but is not a problem anymore, 2 = is still a small problem, 3 = is a moderate problem, and 4 = a severe problem. A maximum score is 128 points.

  baseline and 1 year and 2 years after the neuropsychological assessment

• Multidimensional Fatigue Inventory-20

  The MFI-20 consists of five scales, based on different modes of expressing fatigue. Each scale contains four items for which the subject indicates on a seven-point scale to what extent the statement applies best. 'General fatigue' includes general statements concerning a person's functioning. 'Physical fatigue' refers to the physical sensation related to the feeling of tiredness. 'Reduced activities' measures reduction in activities and 'Reduced motivation' lack of motivation. 'Mental fatigue' measures cognitive symptoms related to fatigue. Some sentences are inverted and need to be rescored. On each scales the higher values the higher fatigue.

  baseline and 1 year and 2 years after the neuropsychological assessment

• The Montreal Cognitive Assessment (MoCA)

  A rapid screening test consisting of seven different domains including 1) visuospatial/executive functions, 2) naming, 3) memory, 4) attention, 5) language, 6) abstraction, and 7) orientation. The total score is 30 points +1 point adjustment for low education); normal functioning is considered from score of 26 and above.

  baseline and 1 year and 2 years after the neuropsychological assessment

Secondary Outcomes (8)

• Visual Analog Scale of Fatigue

  baseline

• D-KEFS Word Fluency Test

  baseline

• WAIS-IV Digit Span

  baseline

• Convergence Insufficiency Symptom Survey (CISS)

  baseline

• Brain Injury Vision Symptom Survey measuring general vision-related symptoms (BIVSS)

  baseline

Other Outcomes (9)

• Sniffn' sticks

  baseline

• Anatomical MRI

  baseline

• Other visual functions

  baseline

Study Arms (2)

Post-COVID condition

Patients experiencing persisting cognitive dysfunction and fatigue after a SARS-CoV-2 infection, three months or more after the infections

Diagnostic Test: Neuropsychological investigation; Diagnostic Test: Optometric investigation; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Immunological biomarkers

Non-symptomatic controls

Persons experiencing no symptoms after the SARS-CoV-2 infection or have not been subject for at SARS-CoV-2 infection

Diagnostic Test: Neuropsychological investigation; Diagnostic Test: Optometric investigation; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Immunological biomarkers

Interventions

Neuropsychological investigation DIAGNOSTIC_TEST

Comprehensive neuropsychological test battery covering logical reasoning, different attention functions, executive functions, visuospatial functions, different memory functions, psychomotor speed, motor functions, and smell identification

Non-symptomatic controls; Post-COVID condition

Optometric investigation DIAGNOSTIC_TEST

Extended vision examination including symptom assessment, visual acuity, visual field (confrontation), eye movements, eye teaming and clinical assessment of hypersensitivity to visual stimuli.

Non-symptomatic controls; Post-COVID condition

Magnetic Resonance Imaging DIAGNOSTIC_TEST

The MRI sequence protocol includes resting state fMRI before and after the participants do an established 20 min long reaction time measurement paradigm (E-prime). During the paradigm a pseudo-continious arterial spin labeling sequence (pCASL) is acquired for continuous measurement of brain perfusion. Following the functional sequences the imaging protocol also includes a high resolution 3D T1weighted sequence Magnetization Prepared Rapid Gradient Echo (MPRAGE) for brain structure, a high resolution 3D T2-weighted sequence Fluid-Attenuated Inversion Recovery (FLAIR) for pathology and a 3D susceptibility weighted image (SWI) for microvascular abnormalities.

Non-symptomatic controls; Post-COVID condition

Immunological biomarkers DIAGNOSTIC_TEST

Venous blood samples (10-20 ml) are taken from the elbow crease. They are drawn in the morning, and the participants are asked to fast for 12 hours prior to sampling. They are also asked to avoid physical activity prior to blood sampling. The samples are drawn into citrated tubes.

Non-symptomatic controls; Post-COVID condition

Eligibility Criteria

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

Study Population

Outpatients with long term (\>3 months) cognitive symptoms and fatigue after a SARS-CoV-2 infection and present at the Department of Rehabilitation Medicine at Danderyd University Hospital

You may qualify if:

• Persons 18 years and older with a history of (\> 3 months) verified COVID-19 (PCR / rapid test / antibody) or an infection that is most likely a SARS-CoV-2 infection (e.g., a close relative had a verified infection that coincided in time with the patient's illness) and who have persistent problems with cognitive impairment or fatigue affecting the return to previous activities / employment.

You may not qualify if:

• Dominant recurrent and / or fluctuating symptoms of infection, circulatory, respiratory or cardiac problems.
• Co-morbidities that may cause cognitive impairment such as neurodegenerative disease, substance abuse, severe mental illness (eg. schizophrenia, mano depressive disorder) or severe depression.
• Not fluent in Swedish, as test and self-reports rely on good mastering of the Swedish language.
• Severe premorbid visual impairment.
• Additionally for the fMRI study:
• Not verified SARS-CoV-2 infection with a Polymerase Chain Reaction (PCR) / rapid test / antibody review
• Traumatic brain injury
• Neuropsychiatric disease such as diagnosed ADHD or autism
• Younger than 25 years or older than 55 years (to avoid the risk that the brain is not fully developed or that there is a risk of age-related changes in the brain).
• MRI contraindications (such as metal objects in the body, fear of cramped spaces, pregnancy, body weight over 130 kg), and left-handedness (to increase the likelihood of uniform topological lateralization in the cohort).

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator
• Karolinska University Hospital: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Stockholm, 18288, Sweden

RECRUITING

Related Publications (35)

• Tsampasian V, Elghazaly H, Chattopadhyay R, Debski M, Naing TKP, Garg P, Clark A, Ntatsaki E, Vassiliou VS. Risk Factors Associated With Post-COVID-19 Condition: A Systematic Review and Meta-analysis. JAMA Intern Med. 2023 Jun 1;183(6):566-580. doi: 10.1001/jamainternmed.2023.0750.

  PMID: 36951832 BACKGROUND

• Al-Aly Z, Bowe B, Xie Y. Long COVID after breakthrough SARS-CoV-2 infection. Nat Med. 2022 Jul;28(7):1461-1467. doi: 10.1038/s41591-022-01840-0. Epub 2022 May 25.

  PMID: 35614233 BACKGROUND

• Graham EL, Clark JR, Orban ZS, Lim PH, Szymanski AL, Taylor C, DiBiase RM, Jia DT, Balabanov R, Ho SU, Batra A, Liotta EM, Koralnik IJ. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. doi: 10.1002/acn3.51350. Epub 2021 Mar 30.

  PMID: 33755344 BACKGROUND

• Premraj L, Kannapadi NV, Briggs J, Seal SM, Battaglini D, Fanning J, Suen J, Robba C, Fraser J, Cho SM. Mid and long-term neurological and neuropsychiatric manifestations of post-COVID-19 syndrome: A meta-analysis. J Neurol Sci. 2022 Mar 15;434:120162. doi: 10.1016/j.jns.2022.120162. Epub 2022 Jan 29.

  PMID: 35121209 BACKGROUND

• Ceban F, Ling S, Lui LMW, Lee Y, Gill H, Teopiz KM, Rodrigues NB, Subramaniapillai M, Di Vincenzo JD, Cao B, Lin K, Mansur RB, Ho RC, Rosenblat JD, Miskowiak KW, Vinberg M, Maletic V, McIntyre RS. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022 Mar;101:93-135. doi: 10.1016/j.bbi.2021.12.020. Epub 2021 Dec 29.

  PMID: 34973396 BACKGROUND

• Klironomos S, Tzortzakakis A, Kits A, Ohberg C, Kollia E, Ahoromazdae A, Almqvist H, Aspelin A, Martin H, Ouellette R, Al-Saadi J, Hasselberg M, Haghgou M, Pedersen M, Petersson S, Finnsson J, Lundberg J, Falk Delgado A, Granberg T. Nervous System Involvement in Coronavirus Disease 2019: Results from a Retrospective Consecutive Neuroimaging Cohort. Radiology. 2020 Dec;297(3):E324-E334. doi: 10.1148/radiol.2020202791. Epub 2020 Jul 30.

  PMID: 32729812 BACKGROUND

• Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.

  PMID: 32367170 BACKGROUND

• Heslin KP, Haruna A, George RA, Chen S, Nobel I, Anderson KB, Faraone SV, Zhang-James Y. Association Between ADHD and COVID-19 Infection and Clinical Outcomes: A Retrospective Cohort Study From Electronic Medical Records. J Atten Disord. 2023 Jan;27(2):169-181. doi: 10.1177/10870547221129305. Epub 2022 Oct 20.

  PMID: 36264064 BACKGROUND

• Dobryakova E, DeLuca J, Genova HM, Wylie GR. Neural correlates of cognitive fatigue: cortico-striatal circuitry and effort-reward imbalance. J Int Neuropsychol Soc. 2013 Sep;19(8):849-53. doi: 10.1017/S1355617713000684. Epub 2013 Jul 10.

  PMID: 23842042 BACKGROUND

• Nordin LE, Moller MC, Julin P, Bartfai A, Hashim F, Li TQ. Post mTBI fatigue is associated with abnormal brain functional connectivity. Sci Rep. 2016 Feb 16;6:21183. doi: 10.1038/srep21183.

  PMID: 26878885 BACKGROUND

• Aceti A, Margarucci LM, Scaramucci E, Orsini M, Salerno G, Di Sante G, Gianfranceschi G, Di Liddo R, Valeriani F, Ria F, Simmaco M, Parnigotto PP, Vitali M, Romano Spica V, Michetti F. Serum S100B protein as a marker of severity in Covid-19 patients. Sci Rep. 2020 Oct 29;10(1):18665. doi: 10.1038/s41598-020-75618-0.

  PMID: 33122776 BACKGROUND

• Cantor F. Central and peripheral fatigue: exemplified by multiple sclerosis and myasthenia gravis. PM R. 2010 May;2(5):399-405. doi: 10.1016/j.pmrj.2010.04.012.

  PMID: 20656621 BACKGROUND

• Tahyra ASC, Calado RT, Almeida F. The Role of Extracellular Vesicles in COVID-19 Pathology. Cells. 2022 Aug 11;11(16):2496. doi: 10.3390/cells11162496.

  PMID: 36010572 BACKGROUND

• Wallensten J, Nager A, Asberg M, Borg K, Beser A, Wilczek A, Mobarrez F. Leakage of astrocyte-derived extracellular vesicles in stress-induced exhaustion disorder: a cross-sectional study. Sci Rep. 2021 Jan 21;11(1):2009. doi: 10.1038/s41598-021-81453-8.

  PMID: 33479350 BACKGROUND

• Kanberg N, Ashton NJ, Andersson LM, Yilmaz A, Lindh M, Nilsson S, Price RW, Blennow K, Zetterberg H, Gisslen M. Neurochemical evidence of astrocytic and neuronal injury commonly found in COVID-19. Neurology. 2020 Sep 22;95(12):e1754-e1759. doi: 10.1212/WNL.0000000000010111. Epub 2020 Jun 16.

  PMID: 32546655 BACKGROUND

• Bruck E, Lasselin J; HICUS study group; Andersson U, Sackey PV, Olofsson PS. Prolonged elevation of plasma HMGB1 is associated with cognitive impairment in intensive care unit survivors. Intensive Care Med. 2020 Apr;46(4):811-812. doi: 10.1007/s00134-020-05941-7. Epub 2020 Feb 26. No abstract available.

  PMID: 32103282 BACKGROUND

• Okuma Y, Wake H, Teshigawara K, Takahashi Y, Hishikawa T, Yasuhara T, Mori S, Takahashi HK, Date I, Nishibori M. Anti-High Mobility Group Box 1 Antibody Therapy May Prevent Cognitive Dysfunction After Traumatic Brain Injury. World Neurosurg. 2019 Feb;122:e864-e871. doi: 10.1016/j.wneu.2018.10.164. Epub 2018 Nov 2.

  PMID: 30391757 BACKGROUND

• Ariza M, Cano N, Segura B, Adan A, Bargallo N, Caldu X, Campabadal A, Jurado MA, Mataro M, Pueyo R, Sala-Llonch R, Barrue C, Bejar J, Cortes CU; NAUTILUS-Project Collaborative Group; Junque C, Garolera M. Neuropsychological impairment in post-COVID condition individuals with and without cognitive complaints. Front Aging Neurosci. 2022 Oct 20;14:1029842. doi: 10.3389/fnagi.2022.1029842. eCollection 2022.

  PMID: 36337708 BACKGROUND

• Kelly KM, Anghinah R, Kullmann A, Ashmore RC, Synowiec AS, Gibson LC, Manfrinati L, de Araujo A, Spera RR, Brucki SMD, Tuma RL, Braverman A, Kiderman A. Oculomotor, vestibular, reaction time, and cognitive tests as objective measures of neural deficits in patients post COVID-19 infection. Front Neurol. 2022 Sep 12;13:919596. doi: 10.3389/fneur.2022.919596. eCollection 2022.

  PMID: 36188407 BACKGROUND

• Marinho PM, Marcos AAA, Romano AC, Nascimento H, Belfort R Jr. Retinal findings in patients with COVID-19. Lancet. 2020 May 23;395(10237):1610. doi: 10.1016/S0140-6736(20)31014-X. Epub 2020 May 12. No abstract available.

  PMID: 32405105 BACKGROUND

• Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.

  PMID: 7636775 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144.

  PMID: 14994958 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Wechsler D. WAIS-IV technical and interpretive manual. San Antonio, Tex.: Psychological Corporation: Pearson; 2008.

  BACKGROUND

• Delis DC, Kaplan E, Kramer JH. D-KEFS. Examiner´s manual. San Antonio: The Psychological Corporation, a Harcourt Assessment Company; 2001.

  BACKGROUND

• Kobal G, Hummel T, Sekinger B, Barz S, Roscher S, Wolf S. "Sniffin' sticks": screening of olfactory performance. Rhinology. 1996 Dec;34(4):222-6.

  PMID: 9050101 BACKGROUND

• Buschke H. Selective reminding for analysis of memory and learning. Journal of Verbal Learning & Verbal Behavior. 1973;12(5):543-50.

  BACKGROUND

• Meyers JE, Meyers KR. Rey Complex Figure Test and Recognition Trial Professional Manual. Odessa: Psychological Assessment Resources, Inc. ; 1995.

  BACKGROUND

• Ruff RM, Allen CC. Ruff 2 & 7 Selective Attention Test. Lutz: Psychological Assessment Resources, Inc.; 1996.

  BACKGROUND

• Garzia RP, Richman JE, Nicholson SB, Gaines CS. A new visual-verbal saccade test: the development eye movement test (DEM). J Am Optom Assoc. 1990 Feb;61(2):124-35.

  PMID: 2313029 BACKGROUND

• Moller MC, Nordin LE, Bartfai A, Julin P, Li TQ. Fatigue and Cognitive Fatigability in Mild Traumatic Brain Injury are Correlated with Altered Neural Activity during Vigilance Test Performance. Front Neurol. 2017 Sep 21;8:496. doi: 10.3389/fneur.2017.00496. eCollection 2017.

  PMID: 28983280 BACKGROUND

• Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90. doi: 10.1111/j.1475-1313.2004.00202.x.

  PMID: 15315652 BACKGROUND

• Laukkanen H, Scheiman M, Hayes JR. Brain Injury Vision Symptom Survey (BIVSS) Questionnaire. Optom Vis Sci. 2017 Jan;94(1):43-50. doi: 10.1097/OPX.0000000000000940.

  PMID: 28027193 BACKGROUND

• Lim J, Wu WC, Wang J, Detre JA, Dinges DF, Rao H. Imaging brain fatigue from sustained mental workload: an ASL perfusion study of the time-on-task effect. Neuroimage. 2010 Feb 15;49(4):3426-35. doi: 10.1016/j.neuroimage.2009.11.020. Epub 2009 Nov 24.

  PMID: 19925871 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Astrocyte-derived EV, and Hmbg1. Exploratory targeted analyses using panels of cytokines \& chemokines and neuroinflammation will also be used.

MeSH Terms

Conditions

Cognitive Dysfunction; Mental Fatigue; Fatigue; COVID-19

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kristian Borg, Professor

  Karolinska Institutet

  STUDY DIRECTOR

• Marika C Möller, PhD

  Department of Rehabilitation Medicine, Danderyd University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marika C Möller, PhD

CONTACT

+46812358555; marika.moller@regionstockholm.se

Kristian Borg, Professor

CONTACT

+46704657065; kristian.borg@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 18, 2023
• Study Start: April 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

SE (1)