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Excitability Protocol: Voltage-gated Ion Channels

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05368532
Enrollment
30
Registered
2022-05-10
Start date
2022-07-31
Completion date
2024-03-01
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

OTHERTemperature

The temperature will be reduced for approximately one hour.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Perception threshold for the excitabilityApproximately 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

MeasureTime frameDescription
SensationApproximately 5 minutes to estimate.The investigator will ask the participant to rate the sensation of electrical stimulation by a questionnaire.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026