Skip to content

Multiple Sclerosis (MS) and autonomic dysfunction: Evaluating Peripheral Nervous System involvement using intra-epidermal nerve fibre density (IENFD).

Multiple Sclerosis (MS) and autonomic dysfunction: Evaluating Peripheral Nervous System involvement using intra-epidermal nerve fibre density (IENFD). - SFN in MS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33791
Enrollment
90
Registered
2009-12-15
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

multiple sclerosis small fibre neuropathy

Interventions

None listed

Sponsors

Orbis Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria - age: 18 years and older - clinical definite MS according to the revised McDonald criteria. - Brain MRI fulfilling the revised McDonald criteria. - a clinical stable condition. A clinical stable condition is defined as: a) a clinical state without any new significant symptoms and/or signs as declared by the patient to the best of his/her knowledge over 3 months prior to the study or b) No clear objective changes at neurological examination by the researcher when compared with recorded findings over three month before study entry (if available) c) No methylprednisolone treatment within 3 months before study entry - written informed consent - patients should be ambulant (Expanded Disability Status Scale (EDSS) score of

Exclusion criteria

Exclusion criteria: - patients not meeting the inclusion criteria - use ofmedication that would interfere with ANS assessment, or use of medication that is known to possibly cause peripheral neuropathy - Other illnesses that might cause autonomic impairment (e.g., parkinson(ism), peripheral neuropathy, diabetes mellitus, alcohol abuse [arbitrarily defined as daily consumption of 5 IU or more], renal dysfunction, systemic illnesses)

Design outcomes

Primary

MeasureTime frame
The primary analysis will consider the difference in IENFD between MS patients with symptoms and without symptoms of ANS dysfunction, as well as compared to healthy participants.

Secondary

MeasureTime frame
In secondary analysis the results of the IENFD will be related to the other outcome measures and clinical data.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)