The Use of QST to Characterize Somatosensory Functionality | NCT06439004

Studies
The Use of QST to Characterize Somatosensory Functionality

NCT06439004

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Quantitative Sensory Testing

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2024Actual

Primary Completion Date

Nov 20, 2024Actual

Completion Date

Nov 20, 2024Actual

First Submitted Date

May 27, 2024

First Submission Date that Met QC Criteria

May 27, 2024

First Posted Date

Jun 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Description Module

Brief Summary

Pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. The subjective nature of pain complicates its mapping and treatment. Quantitative Sensory Testing (QST) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. This set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated Aδ and unmyelinated C), as well as large fibers (thickly myelinated Aβ). In this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected.

In this study, the inter-period reproducibility of thirteen QST parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers	Experimental	Healthy volunteers to evaluate the inter-period reproducibility of thirteen QST parameters.	Other: Quantitative Sensory Testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantitative Sensory Testing	Other	Performing QST on the dominant hand, right forearm, right flank and lower back.	Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inter-period reproducibility of QST	Inter-period reproducibility of thirteen different QST parameters on the dominant hand, right forearm, right flank and lower back of healthy volunteers.	Interval of 7 - 21 days between both periods

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntary written informed consent has been obtained prior to any screening procedures.
Subject is ≥ 18 years and ≤ 25 years of age.
Subject is a non-smoker for at least 6 months before the start of the study.
Subject has a body mass index (BMI) between 18-30 kg/m².
Subject is in good general health, based on medical history and vital signs.

Exclusion Criteria:

Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality.
Subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments.
Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse.
Subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit.
Subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results.
Subject is in a situation or has a condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study.
Female subject who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and is not using an adequate contraceptive method.
Subject is participating in another trial which, in the investigator's opinion, might confound the results of the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms