ongitudinal neuropsychological and neuroradiological investigation of cognitive Impairment in early versus late MS and itscorrelation to hippocampal dysfunction (HIPPOCOMS2)

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00007905
• Lead Sponsor: Fachkrankenhaus Hubertusburg gGmbH Klinik für Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-24
• Study Completion: 2016-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Inclusion in previous study (Hippocoms I, 2011)
Written and oral informed consent

Exclusion Criteria

MS relapse within the past 4 weeks
Steroide treatment within last 4 weeks
Exclusion criteria for MRI, e.g. large tattoos, non-removeable piercings, cardiac pacemaker, severe renal insufficiency ((eGFR <30 mL/min/1,73 m2 , Cockcroft formula)
patients with other relevant brain pathologies (e.g.,Meningioma)
severe epiphenomenon (malignant hypertension, uncontrolled diabetes, Malignoma)
visual perception / sight > 0,2 (in one or two eyes)
alcohol abuse
pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences (between and within groups, including baseline data from the 2011 Hippocoms” study) in the cognitive performance in the following tests: <br>• Symbol Digit Modalities Test (SDMT)<br>• Rey auditory verbal learning test (AVLT)<br>• ROC figure (copy, delayed recall)<br>• Alertness (TAP)<br>• Divided attention (TAP)<br>• Mental flexibility (TAP)<br>• Diagnosticum for cerebral damage (DCS Wolfram)<br>• Verbal learning test (VLT)<br>• Nonverbal learning test (NVLT)<br>Differences (between and within groups, including baseline data from the 2011 Hippocoms” study) in the following MRI parameters: <br>• whole brain volume<br>• cortical thickness<br>• hippocampal volume<br>• T1 lesion load<br>• T2 lesion load<br>• number of active lesions<br>Differences (between and within groups, including baseline data from the 2011 Hippocoms” study) in the parameter estimates of the processing capacity assessed by NTVA (neural theory of visual attention): <br>• C<br>• K<br>• t0<br>• my

Secondary Outcome Measures

Name	Time	Method
Prediction of cognitive changes (regression analysis) by baseline processing capacity (NTVA: C, K, t0, my) and by baseline MRI (brain volume, hippocampal volume, cortical thickness, t1 and t2 lesion load).