Establishing Normative Values for Thermal Detection and Pain Threshold Established by the Psi Method

NCT04611048 | Suspended

• 1 other identifier: PsiNorm
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare different methods to assess thermal detection ability in diabetic patients, as a way to monitor and diagnose neurological complications of diabetes mellitus.

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (8)

• Fitted psychometric functions for cold detection obtained with the psi method

  The alpha (threshold; °C) and beta (slope, °C\^-1) terms of the fitted logistic equation

  baseline

• Fitted psychometric functions for warm detection obtained with the psi method

  The alpha (threshold; °C) and beta (slope, °C\^-1) terms of the fitted logistic equation

  baseline

• Fitted psychometric functions for cold pain obtained with the psi method

  The alpha (threshold; °C) and beta (slope, °C\^-1) terms of the fitted logistic equation

  baseline

• Fitted psychometric functions for heat pain obtained with the psi method

  The alpha (threshold; °C) and beta (slope, °C\^-1) terms of the fitted logistic equation

  baseline

• Cold detection threshold (protocol of the German Research Network on Neuropathic Pain - DFNS)

  average of 3 measurement of the threshold with the method of limits, as described in the protocol of the German Research Network on Neuropathic Pain - DFNS

  baseline

• Cold pain threshold (protocol of the German Research Network on Neuropathic Pain - DFNS)

  average of 3 measurement of the threshold with the method of limits, as described in the protocol of the German Research Network on Neuropathic Pain - DFNS

  baseline

• Warm detection threshold (protocol of the German Research Network on Neuropathic Pain - DFNS)

  average of 3 measurement of the threshold with the method of limits, as described in the protocol of the German Research Network on Neuropathic Pain - DFNS

  baseline

• Heat Pain threshold (protocol of the German Research Network on Neuropathic Pain - DFNS)

  average of 3 measurement of the threshold with the method of limits, as described in the protocol of the German Research Network on Neuropathic Pain - DFNS

  baseline

Other Outcomes (2)

• Utah Early Neuropathy Scale

  baseline

• Toronto clinical neuropathy score

  baseline

Study Arms (1)

Main study

EXPERIMENTAL

Several electrophysiological and behavioural tests will be performed to properly diagnose the patients/check that the healthy controls do not suffer of neuropathy.

Diagnostic Test: Thermal QST (CDT, WDT, CPT, HPT) with the method of limits; Diagnostic Test: Thermal QST (cold and warm detection, heat pain) with the psi method; Diagnostic Test: Neurological examination

Interventions

Thermal QST (CDT, WDT, CPT, HPT) with the method of limits DIAGNOSTIC_TEST

The testing will be carried out using the classical method of limits, i.e. a continuous heating/cooling stimulus will be applied to the skin at a rate of 1°C/s, until the subject signals that he/she felt the targeted sensation by pressing a button (Rolke, Baron, et al., 2006). The temperature reached by the time the subject pressed the button will be considered the threshold. Baseline temperature will be set at 32°C. The stimuli will not go lower than 0°C and higher than 50°C.

Main study

Thermal QST (cold and warm detection, heat pain) with the psi method DIAGNOSTIC_TEST

The Psi algorithm is a method using Bayesian statistics to determine not only the threshold but also the slope of the psychometric function (relationship between the intensity of a stimulus and its detection probability; Kingdom \& Prins, 2010). The algorithm selects the next stimulus intensity to be the most informative on the parameters of interest, based on the prior probability density. After each stimulation, the subject will be asked if he/she felt it (as painful) or not. Based on that answer, a posterior probability density is computed. This posterior is then used as prior for the next stimulation. The stimuli will last maximum 1 s and temperature will be kept between 0°C and 60°C.

Main study

Neurological examination DIAGNOSTIC_TEST

A standardized neurological examination will be performed to assess all the items included in the Utah Early Neuropathy Scale (UENS ) (Singleton et al., 2008) and the Toronto Clinical Neuropathy Score (TCNS)(Perkins, Olaleye, Zinman, \& Bril, 2001). This will include: questions about symptoms (presence or absence of foot pain, numbness, tingling, weakness, imbalance and upper limb symptoms); evaluation of knees and ankles deep tendon reflexes; evaluation of pinprick, temperature, light touch, vibration (128 Hz tuning fork) compared to that of an unaffected sites (e.g., sternum); position sensation in the big toes; mapping of pinprick sensitivity in the lower leg; and evaluation of the active extension of the big toes. Pinprick evaluation will be performed using a disposable pin designed for that purpose (Medipin, The United-Kingdom).

Main study

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Alcohol beverage intake \>3 units/day
• Habitual substance abuse
• History of chemotherapy
• Scar or dermatological condition at the site of stimulation (forearm and hands, leg and foot)
• History of neurological, psychiatric or metabolic disorder other than Diabetes Mellitus (screening will be performed with the patient)
• Currently taking drugs that could induce neuropathy (screening will be performed with the patient)
• For healthy controls: Suffering of chronic pain

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (1)

Institute of Neuroscience

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Small Fiber Neuropathy

Interventions

Cold Temperature; Neurologic Examination

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• André Mouraux, MD, PhD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy volunteers will be tested in this study, in order to establish normative values for the new procedure (psi method)

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: November 2, 2020
• Study Start: October 10, 2020
• Primary Completion: July 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: SAP will be available on the OSF repository by January 2021. Anonymized data will be freely available (stored on an OSF repository) as supporting material for publication.
• Access Criteria: No restriction

Locations

BE (1)