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Recruiting NCT06503523

The Effects of Performing a Motor Imagery Task on Cortical Excitability During Acute Experimental Muscle Pain and Acute Itch

No phase Interventional Itch Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypertonic Saline, Histamine, Cowhage, Transcranial magnetic stimulation (TMS).
Who it may be relevant to
Registry conditions: Itch, Pain. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Neurophysiological and Psychological Aspects of Itch

Overview

The aim of this project is to determine the effects of performing a motor imagery task on cortical excitability during acute experimental muscle pain (induced by hypertonic saline), acute histaminergic itch (induced by histamine), and non-histaminergic itch stimulation (triggered by Cowhage). We hypothesize that motor imagery will counteract the alterations in cortical excitability observed during experimental muscle pain and both itch models.

Detailed description

Itch and pain share many similarities and dissimilarities in terms of the mechanisms and molecules involved. Many studies have been conducted to explain all the neurophysiological aspects involved in the pain process, and cortical adaptations have been provoked in healthy individuals using experimental pain models. Unfortunately, all these aspects still need to be clarified regarding itch. Has been previously demonstrated that motor imagery can counteracted the pain-induced decrease in corticospinal excitability observed during acute pain, and it has also been proposed as a potential intervention for individuals with pain to restore maladaptive neuroplasticity. However, whether motor imagery can similarly counteract the itch-induced cortical changes remains unclear. Therefore, the aim of this project is to investigate whether motor imagery would counteract the reduction in cortical excitability during acute itch, similar to the effects observed in the context of acute pain.

Interventions

  • Other Hypertonic Saline
    A bolus injection of hypertonic saline (7% NaCl) will be administered to the FDI muscle using a 1 mL syringe with a disposable needle (27G), and the volume of the bolus will be 0.1 mL
  • Other Histamine
    A small drop of histamine dihydrochloride will be applied to a previously determined area on the volar forearm, followed by a prick through the drop
  • Other Cowhage
    This insertion is conducted by forceps using a stereomicroscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
  • Device Transcranial magnetic stimulation (TMS)
    Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMSevoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.

Primary outcome measures

  • Numeric rating scales (NRS) [Time frame: 1 minute after every itch/pain induction]
  • Measuring cortical excitability (TEPs) [Time frame: Baseline]
  • Measuring cortical excitability (TEPs) [Time frame: During Itch/pain stimulation for 10 minutes]
  • Measuring cortical excitability (TEPs) [Time frame: During motor imagery task for 7 minutes]
  • Measuring cortical excitability (TEPs) [Time frame: Post induction of itch or pain]
Secondary outcome measures (7)
  • Pain Catastrophizing Scale (PCS). [Time frame: Baseline]
  • Itch Catastrophizing Scale (ICS). [Time frame: Baseline]
  • Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). [Time frame: Baseline]
  • The Pittsburg Sleep Quality Index (PSQI) [Time frame: Baseline]
  • Depression, Anxiety, Stress Scale (DASS-21) [Time frame: Baseline]
  • Learned Helplessness Scale (LHS) [Time frame: Baseline]
  • Positive And Negative Affect Schedule (PANAS) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Healthy men and women
  • 18-60 years
  • Speak and understand English

Exclusion criteria

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
  • Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder (e.g., heart stroke), or psychiatric diagnoses (e.g. depression) that may affect the results
  • Current use of medications that may affect the trial, such as antihistamines, antipsychotics, and painkillers, as well as systemic or topical steroids
  • Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
  • Moles, scars, or tattoos in the area to be treated or tested.
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain
  • Unable to pass the "Transcranial Magnetic Stimulation Adult Safety Screen" (subproject 1 and 2)
  • Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.)
  • Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos
  • Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
  • Lack of ability to cooperate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 2 centers
  • Aalborg University — Gistrup
  • Aalborg University — Gistrup

Identifiers

NCT: NCT06503523 · N-20240004 2nd subproject

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗