The Effect of Capsaicin-induced Pain on Homeostatic Plasticity in Healthy Human Participants

NCT04485689 | Unknown

• 1 other identifier: N-20190069/2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

People suffering from chronic pain exhibit changes in the way the central nervous system processes pain. Some of the changes in the central nervous system are associated with how the brain adapts to the process of different stimuli. There are several physiological mechanisms that regulates how the brain adapts to changes and one of these mechanisms is called homeostatic plasticity (or equilibrium plasticity ). In healthy participants homeostatic plasticity mechanisms have been tested and considered normal, whereas in patients with chronic conditions, such as low back pain, this mechanism was shown to be dysfunctional. However, it is unknown when this difference in the pain system develops. It is possible that homeostatic mechanism becomes impaired during early stages of pain. This experiment will investigate the effect of capsaicin-induced pain on homeostatic plasticity in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Conspiratorial excitability

  Corticospinal excitability measured as motor evoked potentials amplitude induced by transcranial magnetic stimulation.

  [Time Frame: 0 minutes post homeostatic plasticity induction]

• Conspiratorial excitability

  Corticospinal excitability measured as motor evoked potentials amplitude induced by transcranial magnetic stimulation.

  [Time Frame: 15 minutes post homeostatic plasticity induction]

• Conspiratorial excitability

  Corticospinal excitability measured as motor evoked potentials amplitude induced by transcranial magnetic stimulation.

  [Time Frame: 30 minutes post homeostatic plasticity induction]

• Conspiratorial excitability

  Corticospinal excitability measured as motor evoked potentials amplitude induced by transcranial magnetic stimulation.

  [Time Frame: 45 minutes post homeostatic plasticity induction]

Secondary Outcomes (1)

• Pain intensity

  Every 10 minutes post capsaicin application

Study Arms (4)

Capsaicin - alone

EXPERIMENTAL

5x7 cm2 capsaicin patch

Drug: Capsaicin Topical - alone

Placebo - alone

PLACEBO COMPARATOR

5x7 cm2 placebo patch alone

Drug: Placebo - alone

Capsaicin - ice

EXPERIMENTAL

5x7 cm2 capsaicin patch - plus ice

Drug: Capsaicin Topical - ice

Placebo - ice

PLACEBO COMPARATOR

5x7 cm2 placebo patch - plus ice

Drug: Placebo - ice

Interventions

Capsaicin Topical - alone DRUG

5x7 cm2 capsaicin patch applied on the dorsal area of the hand and left in place for 24 hours

Capsaicin - alone

Placebo - alone DRUG

5x7 cm2 patch applied on the dorsal area of the hand and left in place for 24 hours

Placebo - alone

Capsaicin Topical - ice DRUG

5x7 cm2 capsaicin patch applied on the dorsal area of the hand and left in place for 24 hours. Ice will be applied on top of the patch 1.5 hrs post patch application and left in place for 1 hr.

Capsaicin - ice

Placebo - ice DRUG

5x7 cm2 patch applied on the dorsal area of the hand and left in place for 24 hours. Ice will be applied on top of the patch 1.5 hrs post patch application and left in place for 1 hr.

Placebo - ice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, aged between 18-60 years, right-handed and can speak and understand English.

You may not qualify if:

• Lack of ability to cooperate
• Chili allergy
• History or present chronic pain or current acute pain
• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Present and previous neurological disorders such as epilepsy, Alzheimer's disease,
• dementia, stroke, migraine and other headache disorders, multiple sclerosis,
• Parkinson's disease, neuroinfections, brain tumors and head trauma.
• Present or previous musculoskeletal disorders such as tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
• Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
• Current use of medications that may affect the trial (e.g. analgesics, anti- inflammatories, anti-depressives)
• Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
• Failure to pass the tDCS screening questionnaire
• Failure to pass the "TASS questionnaire"

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

RECRUITING

Related Publications (5)

• Thapa T, Graven-Nielsen T, Chipchase LS, Schabrun SM. Disruption of cortical synaptic homeostasis in individuals with chronic low back pain. Clin Neurophysiol. 2018 May;129(5):1090-1096. doi: 10.1016/j.clinph.2018.01.060. Epub 2018 Feb 9.

  PMID: 29472134 BACKGROUND

• Thapa T, Schabrun SM. Test-Retest Reliability of Homeostatic Plasticity in the Human Primary Motor Cortex. Neural Plast. 2018 Jun 10;2018:6207508. doi: 10.1155/2018/6207508. eCollection 2018.

  PMID: 29983706 BACKGROUND

• Karabanov A, Ziemann U, Hamada M, George MS, Quartarone A, Classen J, Massimini M, Rothwell J, Siebner HR. Consensus Paper: Probing Homeostatic Plasticity of Human Cortex With Non-invasive Transcranial Brain Stimulation. Brain Stimul. 2015 May-Jun;8(3):442-54. doi: 10.1016/j.brs.2015.01.404. Epub 2015 Apr 1.

  PMID: 26050599 BACKGROUND

• Fricke K, Seeber AA, Thirugnanasambandam N, Paulus W, Nitsche MA, Rothwell JC. Time course of the induction of homeostatic plasticity generated by repeated transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2011 Mar;105(3):1141-9. doi: 10.1152/jn.00608.2009. Epub 2010 Dec 22.

  PMID: 21177994 BACKGROUND

• Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.

  PMID: 25797650 BACKGROUND

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Central Study Contacts

Priscilla G Wittkopf, PhD

CONTACT

311539979; pgw@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a within-between subjects comparisons study.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)