Excitability Protocol: Voltage-gated Ion Channels

Not Applicable

Active, not recruiting

• Conditions: Pain

• Registration Number: NCT05368532
• Lead Sponsor: Aalborg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Study Start: 2022-07-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perception threshold for the excitability	Approximately 5 minutes to estimate.	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.

Secondary Outcome Measures

Name	Time	Method
Sensation	Approximately 5 minutes to estimate.	The investigator will ask the participant to rate the sensation of electrical stimulation by a questionnaire.

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Denmark