Excitability Protocol: Voltage-gated Ion Channels

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05368532
• Other study ID #: N-2020001-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 31, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Temperature
The temperature will be reduced for approximately one hour.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensation	The investigator will ask the participant to rate the sensation of electrical stimulation by a questionnaire.	Approximately 5 minutes to estimate.