Characterisation of the skeletal muscles of patients with facioscapulohumeral muscular dystrophy by quantitative 1H and X-nuclei MRI

Characterisation of the skeletal muscles of patients with facioscapulohumeral muscular dystrophy by quantitative 1H and X-nuclei MRI - 23_FSDH_MRI_UKER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031901

Enrollment

Registered

2023-06-14

Start date

2023-08-14

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

G71.0

Interventions

Group 1: The lower leg muscles of 30 patients with facioscapulohumeral muscular dystrophy aged 18 years and older are examined a total of two times at one-year interval using 23Na, 39K and 1H MRI. Gro

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Ambulant, at least for short distances. - Willingness and ability to participate, sufficient knowledge of German to understand the declaration of consent, or if not possible, test subject information and support in the mother tongue or, if necessary, in English - Probability that the subjects/patients can complete the study (defined by the ability to lie still for approximately 1 hour)

Exclusion criteria

Exclusion criteria: - General contraindications for MRI examinations - Electrical implants such as cardiac pacemakers or perfusion pumps - Pronounced claustrophobia - Study participants with ferromagnetic or electrically conductive implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, heart valves with metal parts, metal splinters, tattoos near the eye, symmetrical tattoos on the extremities or steel implants must be discussed with the study physician; they may not be examined (relative contraindications for MRI). - Prohibited concomitant medication: Strongly sedating medications are to be ruled out, since intensive monitoring of body functions during ongoing imaging cannot be guaranteed and the examination is dependent on the active participation of the subject.

Design outcomes

Primary

Measure	Time frame
Fat fraction (FF) and total sodium concentration (TSC) in lower leg muscle. 1 and 12 months in patients Once in healthy controls	—

Secondary

Measure	Time frame
Water T2 and T1 (transverse and longitudinal relaxation times) and total potassium concentration (TPC) in lower leg muscles	—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactTeresa Gerhalter

MR-Physik am Universitätsklinikum Erlangen

teresa.gerhalter@uk-erlangen.de+49 9131 85-22309

Outcome results

None listed

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