Excitability Protocol: Voltage-gated Ion Channels

Novel Excitability Protocol to Identify Alteration of Voltage-gated Ion Channels

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain
• Intervention / Treatment: Other: Temperature

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Tigerholm; Phone Number: 99403451; Email: jvt@hst.aau.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Healthy men and women in the age 18-80 years who speak and understand English.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation	The investigator will ask the participant to rate the sensation of electrical stimulation by a questionnaire.	Approximately 5 minutes to estimate.

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Jenny Tigerholm, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N-2020001-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No