NL-OMON53010
Recruiting
Not Applicable
Improving the clinical usefulness of skin biopsy in small fiber neuropathy: examining the intraepidermal nerve fiber density dynamic longitudinally and the importance of adding the proximal/distal ratio - Improving the clinical usefulness of skin biopsy in small fiber neuropathy
Medisch Universitair Ziekenhuis Maastricht0 sites280 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- small fiber neuropathy
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 280
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1 (n\=40\) Idiopathic SFN, with normal IENFD:
- •a) Male and female subjects of 18 years or older.
- •b) \>\=2 positive answers on the SFN\-SIQ, not otherwise explained.
- •c) Normal IENFD and abnormal TTT, according to the international normative
- •values,3,23 during the regular visit in our clinical center at least one year
- •d) Written informed consent.Group 2 (n \= 40\) Sodium channelopathy\-related SFN,
- •with normal IENFD:
- •a) Male and female subjects of 18 years or older.
- •b) \>\=2 positive answers on the SFN\-SIQ, not otherwise explained.
- •c) Normal IENFD and abnormal TTT, according to the international normative
Exclusion Criteria
- •All patient groups:
- •a) Underlying cause of SFN (diabetes, hypothyroidism, renal failure, vitamin
- •B12 deficiency, monoclonal gammopathy, alcohol abuse (more than 5 IU/day),
- •malignancies, drugs that cause neuropathy (e.g. chemotherapy, amiodarone,
- •propafenone)).
- •b) Large nerve fiber involvement (i.e. weakness, loss of vibration sense,
- •hypo\-/areflexia, abnormal nerve conduction studies).Groups 1, 4 and 5
- •a) Possibly pathogenic, probably pathogenic or pathogenic NaV1\.7, Nav1\.8 and/or
- •NaV1\.9 variant.Healthy subjects
- •a) \>1 positive answer on the SFN\-SIQ.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Not Applicable
Clinical Usefulness of Optical Skin BiopsySkin NeoplasmsNCT00154921National Taiwan University Hospital30
Completed
Not Applicable
The impact skin biopsy by hospitalists in the diagnosis of skin diseaseSkin diseaseJPRN-UMIN000050098Akashi Medical Center44
Recruiting
Not Applicable
Skin biopsy as diagnostic tool in anterior cutaneous nerve entrapment syndrome (ACNES): A Pilot StudyChronic abdominal wall pain (CAWP)Neuropathic abdominal wall pain10034606NL-OMON53881Maxima Medisch Centrum12
Recruiting
Not Applicable
Clinical and dermoscopic evaluation of wound healing at skin punch biopsy site in various skin dermatosesCTRI/2023/06/053730DR SHIVANGI ARORA
Completed
Not Applicable
Identifying Skin Biopsy SitesIdentification of Skin Cancer Biopsy SitesNCT01632644Northwestern University59