Excitability Protocol: Voltage-gated Ion Channels

Sponsor

Aalborg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05368532

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Temperature	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University	Aalborg		Denmark	9000

Sponsors and Collaborators

Aalborg University

Investigators

Principal Investigator: Jenny Tigerholm, Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jenny Tigerholm, Assistant Professor, Aalborg University

ClinicalTrials.gov Identifier:

NCT05368532

Other Study ID Numbers:

N-2020001-1

First Posted:

May 10, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 27, 2022