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Excitability Protocol: Voltage-gated Ion Channels

A

Aalborg University

Status

Active, not recruiting

Conditions

Pain

Treatments

Other: Temperature

Study type

Interventional

Funder types

Other

Identifiers

NCT05368532
N-2020001-1

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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
  • Patients with cardiac diseases (e.g., pacemaker).

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Jenny Tigerholm

Data sourced from clinicaltrials.gov

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