Excitability Protocol: Voltage-gated Ion Channels

NCT05368532 | Unknown DMC

• 1 other identifier: N-2020001-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of subproject 1 is to evaluate the accuracy of a nerve excitability protocol in healthy subjects before testing the protocol in diabetic neuropathy patients. The nerve excitability protocol has been derived by computational modeling to identify abnormalities of three subtypes of ion voltage-gated channels. These three ion channels are all altered in animal models of diabetic neuropathy and, therefore, are likely candidates for generating the altered excitability in diabetic neuropathy patients. The hypothesis for subproject 1 is that due to the unique dynamics of each subtype of voltage-gated ion channels, it is possible to identify abnormal voltage-gated ion channel alterations by altering the shape of the electrical stimulation.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Perception threshold for the excitability

  The perception threshold will be estimated for a set of electrical stimuli. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.

  Approximately 5 minutes to estimate.

Secondary Outcomes (1)

• Sensation

  Approximately 5 minutes to estimate.

Interventions

Temperature OTHER

The temperature will be reduced for approximately one hour.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnancy or breast feeding
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
• Skin diseases
• Past history of conditions possibly leading to neuropathy
• Inability to cooperate
• Current use of medications that may affect the study, e.g., analgesics
• Previous traumatic experience of an electrical accident
• Consumption of alcohol or painkillers within the last 24 hours
• Participation in other pain studies throughout the study period
• Patients with cardiac diseases (e.g., pacemaker).

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Temperature

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health

Study Officials

• Jenny Tigerholm

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: July 31, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)