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

NCT06503523 | Recruiting DMC

• 1 other identifier: N-20240004 2nd subproject
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Itch; Pain

Outcome Measures

Primary Outcomes (5)

• Numeric rating scales (NRS)

  NRS are essentially VAS but have tick marks spaced every centimeter so as to create 11-point scale (from 0 to 10). Subject can use these tick marks as a guide when they mark their severity on the scale.

  1 minute after every itch/pain induction

• Measuring cortical excitability (TEPs)

  Transcranial magnetic stimulation (TMS) with a figure-eight-shaped cone coil will be used to evoke cortical responses in the motor cortex. The resulting TMS-evoked potentials (TEPs) will be collected using an electroencephalogram (EEG). This assessment will last for 7 minutes before inducing itch or pain.

  Baseline

• Measuring cortical excitability (TEPs)

  Transcranial magnetic stimulation (TMS) with a figure-eight-shaped cone coil will be used to evoke cortical responses in the motor cortex. The resulting TMS-evoked potentials (TEPs) will be collected using an electroencephalogram (EEG). This assessment will last for 7 minutes during itch or pain. The pain or itch sensation will last 10 minutes.

  During Itch/pain stimulation for 10 minutes

• Measuring cortical excitability (TEPs)

  Transcranial magnetic stimulation (TMS) with a figure-eight-shaped cone coil will be used to evoke cortical responses in the motor cortex. The resulting TMS-evoked potentials (TEPs) will be collected using an electroencephalogram (EEG). This assessment will last for 7 minutes during motor imagery task.

  During motor imagery task for 7 minutes

• Measuring cortical excitability (TEPs)

  Transcranial magnetic stimulation (TMS) with a figure-eight-shaped cone coil will be used to evoke cortical responses in the motor cortex. The resulting TMS-evoked potentials (TEPs) will be collected using an electroencephalogram (EEG). Similar to the baseline, this assessment will last for 7 minutes after itch or pain.

  Post induction of itch or pain

Secondary Outcomes (7)

• Pain Catastrophizing Scale (PCS).

  Baseline

• Itch Catastrophizing Scale (ICS).

  Baseline

• Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).

  Baseline

• The Pittsburg Sleep Quality Index (PSQI)

  Baseline

• Depression, Anxiety, Stress Scale (DASS-21)

  Baseline

Study Arms (1)

Experimental:Healthy volunteers

EXPERIMENTAL

Other: Hypertonic Saline; Other: Histamine; Other: Cowhage; Device: Transcranial magnetic stimulation (TMS)

Interventions

Hypertonic Saline OTHER

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

Experimental:Healthy volunteers

Histamine OTHER

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

Experimental:Healthy volunteers

Cowhage OTHER

This insertion is conducted by forceps using a stereomicroscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.

Experimental:Healthy volunteers

Transcranial magnetic stimulation (TMS) DEVICE

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.

Experimental:Healthy volunteers

Eligibility Criteria

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

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (2)

Aalborg University

Gistrup, 9260, Denmark

RECRUITING

Aalborg University

Gistrup, 9260, Denmark

RECRUITING

MeSH Terms

Conditions

Pruritus; Pain

Interventions

Saline Solution, Hypertonic; Histamine; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Magnetic Field Therapy; Therapeutics

Central Study Contacts

Silvia Lo Vecchio

CONTACT

21397785; slv@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: we apply one of three experimental methods in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%)

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

DK (2)