Excitability Protocol: Voltage-gated Ion Channels

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Temperature


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Temperature|The temperature will be reduced for approximately one hour.|

What is the study measuring?
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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. |