- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07932366
Effect of Pre-heat Conditioning on Histaminergic Itch
Investigating the Neurophysiology of Itch
This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine in one or multiple injection sites
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Silvia Lo Vecchio
- Telefonnummer: 21397785
- E-mail: slv@hst.aau.dk
Studiesteder
-
-
Aalborg
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Gistrup, Aalborg, Danmark, 9260
- Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
-
Kontakt:
- Silvia Lo Vecchio
- Telefonnummer: 21397785
- E-mail: slv@hst.aau.dk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy men and women
- 18-60 years
- Speak and understand English
Exclusion Criteria:
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g., neuropathy), immunological (e.g., asthma, immune deficiencies, arthritis), musculoskeletal (e.g., muscular pain in the upper extremities), cardiac disorder (e.g., stroke), or psychiatric diagnoses (e.g., depression, bipolar disorders, acute and chronic psychosis).
- ) that may affect the results
- Current use of medications that may affect the trial, such as antihistamines, antipsychotics, painkillers, and systemic or topical steroids
- Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
- Moles, scars, or tattoos in the area to be treated or tested (forearm/hand).
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" (subprojects 2-4)
- Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.) (subprojects 2-4)
- Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos (subprojects 2-4)
- Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application sites (subprojects 2, 3, and 4)
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials) The subject is assessed as unable to engage in the necessary cooperation required by the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Heat pre-conditioning
38 °C x 5 min |
38 °C x 5 min To deliver histamine, standard allergy skin prick test (SPT) lancets are applied To deliver histamine, standard allergy skin prick test (SPT) lancets are applied |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Superficial blood perfusion
Tidsramme: Before pruritogen application
|
Before pruritogen application
|
|
|
Superficial blood perfusion
Tidsramme: 1 minute after pruritogen removal
|
1 minute after pruritogen removal
|
|
|
Measuring Itch by computerized Visual Analog Scale Scoring
Tidsramme: During Histamine application
|
We will ask the subjects to rate the sensation of itch on a 100 |
During Histamine application
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alloknesis
Tidsramme: Before pruritogen application
|
is measured by using a brush |
Before pruritogen application
|
|
Alloknesis
Tidsramme: 2 minutes after pruritogen removal
|
is measured by using a brush |
2 minutes after pruritogen removal
|
|
Mechanically evoked itch (MEI)
Tidsramme: Before pruritogen application
|
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). |
Before pruritogen application
|
|
Mechanically evoked itch (MEI)
Tidsramme: 5 minute after pruritogen removal
|
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). |
5 minute after pruritogen removal
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- N-20250026 Project 1b
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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