Molecular, genetic and neuroimaging mechanisms of relapse recovery in multiple sclerosis: exploring the role of brain-derived neurotrophic factor

Molecular, genetic and neuroimaging mechanisms of relapse recovery in multiple sclerosis: exploring the role of brain-derived neurotrophic factor - LIONHEARTED (moLecular, genetIc and neurOimagiNg mecHanisms of rElApse recovery in multiple sclerosis: exploRing The role of brain-derivED neurotrophic factor)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031011

Enrollment

200

Registered

2023-01-03

Start date

2023-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Adult subjects with relapsing MS T0: Baseline (at study enrolment) • demographic and clinical information • physical disability quantified by EDSS • cognitive deficits quantified by BICAMS •

Eligibility

Sex/Gender

All

Age

6 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the adult MS group: ability to give informed consent; age 18-60 years; relapsing MS; disease duration = 10 years; last relapse and IVMP/plasmapheresis/immunoadsorption > 30 days ago; no DMT or stable on DMT for the last = 6 months. Inclusion criteria for the pediatric MS group: parents’ ability to give informed consent; age 6-17 years; relapsing MS; disease duration = 15 years; last relapse and IVMP/plasmapheresis/immunoadsorption > 30 days ago; no DMT or stable on DMT for the last 6 months.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the adult MS group: no ability to give informed consent, age 60 years; progressive MS with no relapses; disease duration > 10 years; last relapse and IVMP/plasmapheresis/immunoadsorption = 30 days ago; DMT initiation or not stable on DMT in the last 18 years; progressive MS with no relapses; disease duration > 15 years; last relapse and IVMP/plasmapheresis/immunoadsorption = 30 days ago; DMT initiation or not stable on DMT in the last 6 months.

Design outcomes

Primary

Measure	Time frame
3-month confirmed disability improvement after relapse	—

Secondary

Measure	Time frame
1) Relapse-induced BDNF serum concentration change, labelled as ?BDNF and defined as (BDNFT1 – BDNFT0)/ BDNFT0 (difference in BDNF serum concentration between relapse (T1) and baseline (T0) adjusted for baseline serum concentration). 2) (BDNFT1 – BDNFT2)/ BDNFT0 3) (BDNFT1 – BDNFT3)/ BDNFT0 4) (BDNFT1 – BDNFT4)/ BDNFT0 5) ?BICAMS = (BICAMST4 – BICAMST1)/(BICAMST0 – BICAMST1) 6) ?QIDS = (QIDST1 – QIDST4)/(QIDST1 – QIDST0) 7) ?number of MRI T2-lesions (?nrT2LES) = nrT2LEST1 – nrT2LEST4 8) ?volume of MRI T2-lesions (?volT2LES) = volT2LEST1 – volT2LEST4 9) ?qT1 10) ?qT2 11) ?31P-NMR spectroscopy 12) time to relapse (months)	—

Measure

Time frame

1) Relapse-induced BDNF serum concentration change, labelled as ?BDNF and defined as (BDNFT1 – BDNFT0)/ BDNFT0 (difference in BDNF serum concentration between relapse (T1) and baseline (T0) adjusted for baseline serum concentration). 2) (BDNFT1 – BDNFT2)/ BDNFT0 3) (BDNFT1 – BDNFT3)/ BDNFT0 4) (BDNFT1 – BDNFT4)/ BDNFT0 5) ?BICAMS = (BICAMST4 – BICAMST1)/(BICAMST0 – BICAMST1) 6) ?QIDS = (QIDST1 – QIDST4)/(QIDST1 – QIDST0) 7) ?number of MRI T2-lesions (?nrT2LES) = nrT2LEST1 – nrT2LEST4 8) ?volume of MRI T2-lesions (?volT2LES) = volT2LEST1 – volT2LEST4 9) ?qT1 10) ?qT2 11) ?31P-NMR spectroscopy 12) time to relapse (months)

—

Countries

Germany

Contacts

Public ContactYavor Yalachkov

Klinik für Neurologie, Universitätsklinikum Frankfurt

yavor.yalachkov@kgu.de+49 69 6301 4310

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026