Central pain location in SCN9A-associated SFN: an fMRI pilot study. - fMRI in small fiber neuropathy

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

适应症

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•Patient group (SCN9A-associated SFN) (n <= 20)
•a. Male and/or female subjects between the ages of 18 and 80 years.
•b. Presence of a clinical diagnosis of small fiber neuropathy, according to
•international criteria and presence of confirmed abnormality on intra-epidermal
•nerve fiber density evaluation and/or Quantitative Sensory Testing.
•c. A mutation in the SCN9A gene, confirmed by sequencing, with possible,
•probable or certain pathogenicity according to international criteria.
•d. Presence of pain due to SFN for at least 3 months and an average
•self-reported pain score of at least 5.
•e. Subjects must give informed consent by signing and dating an informed
•consent form., Patient group (SFN without a gene mutation)
•a. Male and/or female subjects between the ages of 18 and 80 years.
•b. Presence of a clinical diagnosis of SFN, according to international
•criteria,1, 52, 53 including a decreased intra-epidermal nerve fiber density
•IENFD in skin biopsy.
•c. No mutation in the SCN9A, SCN10A or SCN11A gene, confirmed by sequencing.
•d. Presence of pain due to SFN for at least 3 months and an average
•self-reported pain score of at least 5.
•e. Subjects must give informed consent by signing and dating an informed
•consent form., Control group (n <= 20)
•a. Male and/or female subjects between the ages of 18 and 80 years.
•b. Subjects must give informed consent by signing and dating an informed
•consent form.

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•a. Major depression according to DSM-V criteria or a history of major
•psychiatric disease.
•b. (History with) alcohol abuse
•c. Hospital Anxiety and Depression Scale (HADS) * 14
•d. Subjects who have another pain syndrome than small fiber neuropathy.
•e. Contraindications for undergoing MRI: pacemaker, metallic foreign body
•(including aneurysm clip in the brain), claustrophobia, pregnancy,
•neurostimulator, pacemaker or other kinds of implanted devices or insulin pump.
•In case of cardiac valve replacement of ossicular replacement prosthesis the
•radiologist will be consulted.

发起方

Medisch Universitair Ziekenhuis Maastricht