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临床试验/NCT07819162
NCT07819162尚未招募不适用

Neural Dissimilarity: A Promising New fMRI-based Measure of Smell? Changes in the Olfactory System Following Treatment for Severe CRSwNP With Monoclonal Antibodies

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2027年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Representational Similarity Matrix (RDM)

研究概览

简要总结

This project will focus on rehabilitation of olfactory dysfunction in patients with chronic rhinosinusitis with polyps given biological treatment based on functional magnetic resonance imaging.

详细描述

The sense of smell is essential in social interactions, food intake and hazard detection. Olfactory dysfunction (OD) affects approximately 20% of the adults and likely increased following the COVID-19 pandemic. The pandemic highlighted the substantial burden of OD on daily life and well-being.

A common cause of acquired OD is Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) affecting 2-4% of adult Scandinavian population. The vast majority of CRSwNP in this population is driven by type-2 inflammation. Decreased sense of smell is an almost obligatory complaint in severe CRSwNP with an OD prevalences of ~95% and ranked as one of the most important.

OD is the symptom in CRSwNP with greatest effect on health-related quality of life and at the same time remains difficult to treat.

New treatments for patients with severe CRSwNP have recently become available in form of monoclonal antibodies selectively blocking pro-inflammatory cytokines in the type-2-inflammation cascade. These biologics show substantial improvements in self-reported olfactory tests.

Knowledge of neuroanatomical functional and structural correlates to olfactory function has long existed. However, only few have used functional magnetic resonance imaging (fMRI) to investigate OD in CRS patients. Patients with CRS-related OD offer a unique neurobiological model for studying olfactory plasticity as olfaction potentially improves.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or above
  • Olfactory dysfunction (i.e., a TDI score < 30.75)
  • Eligible for treatment with biologics (i.e., meeting the Danish criteria for treatment with biologics (40) which includes fulfillment of the EPOS criteria for CRS.
  • Either treatment naïve to biologics or had their first injection within a maximum of 48 hours prior to the scan.
  • No other obvious explanation for the olfactory dysfunction (including, but not limited to: head trauma, sinus surgery, tumors in the nose or brain, upper respiratory infection, neurological or psychiatric disease)
  • Control group: normosmic at baseline (i.e., TDI-score >30.75)

排除标准

  • Previously recognized loss of sense of smell and taste due to other sinonasal or neurological conditions.
  • Neurodegenerative disorders known to cause olfactory deficits (Parkinson's, Alzheimer's, Lewy-Body Dementia, Amyotrophic lateral Sclerosis etc.)
  • Other obvious explanation for the OD (i.e., smell loss occurring in relation to one of the following (including, but not limited to): head trauma, sinus surgery, upper respiratory infection.
  • Contraindications for MRI scan including:
  • Implants or prostheses of magnetic metal
  • Metal foreign bodies
  • Pregnancy
  • Severe claustrophobia
  • Unable to complete the full MRI session.
  • Not able to comprehend written and/or spoken Danish language.

研究组 & 干预措施

Control

Age-adsjusted, normoosmic and sinus healthy matched controls

CRSwNP with OD

Patients with olfactory dysfunction due to chronic rhinosinusitis with nasal polyps who are navïe to biological treatment

结局指标

主要结局

Representational Similarity Matrix (RDM)

时间窗: From enrollment to 24 weeks +/- 2 weeks

Change in representational dissimilarity matrices (RDMs) derived from functional magnetic resonance imaging (fMRI) data during an odor categorization task. RDMs will be constructed from multivoxel activation patterns elicited by three odor stimuli within predefined olfactory regions of interest

次要结局

  • Threshold-Discrimination-Identification (TDI) score(Baseline and Week 24 (±2 weeks))
  • Correlation between changes in RDM metrics and changes in TDI score.(Baseline and Week 24 (±2 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mads Bolding Rasmussen

M.D., Ph.D fellow

Rigshospitalet, Denmark

研究点 (1)

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