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Clinical Trials/NCT05368532
NCT05368532
Active, not recruiting
Not Applicable

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

Aalborg University1 site in 1 country30 target enrollmentJuly 31, 2022
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Aalborg University
Enrollment
30
Locations
1
Primary Endpoint
Perception threshold for the excitability
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 31, 2022
End Date
March 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Jenny Tigerholm

Assistant Professor

Aalborg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perception threshold for the excitability

Time Frame: 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 Outcomes

  • Sensation(Approximately 5 minutes to estimate.)

Study Sites (1)

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