Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT06003660
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT
Sponsor:
University of Oslo
Organization:
Study Overview
Official Title:
BrainFlavor: Brain Neuronal Networks and Chemosensory and Trigeminal Functions in Allogeneic Hematopoietic Stem Cell Transplantation - a Prospective Cohort-study
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective, cohort study is to learn about smell, taste and trigeminal dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce:
* Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations.
* Reduced saliva production leading to oral dryness and dental caries.
* Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.
* Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations.
* Reduced saliva production leading to oral dryness and dental caries.
* Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.
Detailed Description:
Participants will undergo various tests:
* Smell function assessment with Sniffin' Sticks.
* Taste function assessment with Taste Strips.
* Oral trigeminal function assessment with von Frey filaments .
* Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire.
* Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS).
* A clinical oral examination will be done to obtain a Clinical Oral Dryness Score.
* Qualitative smell, taste and trigeminal dysfunction will be assessed using a questionnaire.
* Radiological and clinical examinations will be performed to evaluate dental and oral mucosal status.
* Quality of life using questionnaire.
* Nutritional status using questionnaire.
* Magnetic resonance imaging of the brain will be taken to capture regions-of-interest for the three different networks of interest; (i) the gustatory network reflecting changes in taste perception, (ii) the olfactory network, related to the changes in smell, and (iii) the pain matrix reflecting pain.
There will be a comparisons between the patients and healthy controls.
* Smell function assessment with Sniffin' Sticks.
* Taste function assessment with Taste Strips.
* Oral trigeminal function assessment with von Frey filaments .
* Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire.
* Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS).
* A clinical oral examination will be done to obtain a Clinical Oral Dryness Score.
* Qualitative smell, taste and trigeminal dysfunction will be assessed using a questionnaire.
* Radiological and clinical examinations will be performed to evaluate dental and oral mucosal status.
* Quality of life using questionnaire.
* Nutritional status using questionnaire.
* Magnetic resonance imaging of the brain will be taken to capture regions-of-interest for the three different networks of interest; (i) the gustatory network reflecting changes in taste perception, (ii) the olfactory network, related to the changes in smell, and (iii) the pain matrix reflecting pain.
There will be a comparisons between the patients and healthy controls.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: