Clinical trial NCT05158309: Measuring and Modulating Changes in EEG Resting State Functional Connectivity During Short-term and Long-term Pain
Official title: Aalborg University, Aalborg, Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pain, EEG, Resting State Functional Connectivity
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Danish National Research Foundation
name: European Commission
First posted: 2021-12-15
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants experienced both experimental (capsaicin) condition and placebo conditions. Due to the long-lasting effects of capsaicin after 24 hours of application, placebo condition always preceded the capsaicin condition.
Primary purpose: BASIC_SCIENCE

Brief summary: Background and aims: Experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsFC). This experiment aimed at examining the effect of 24-hour-capsaicin application on the rsFC of the default mode network (DMN), a prominent network in the dynamic pain connectome.

Methods: Electroencephalographic (EEG) rsFC measured by Granger causality was acquired at baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin). After 24 hours, the patch was cooled down then heated up to assess rsFC changes in response to pain relief and facilitation. Pain was induced using a topical capsaicin patch (or placebo as control) on the right forearm and assessed on a 0-10 numerical rating scale (NRS).


Eligibility criteria: Inclusion Criteria:

Healthy men and women, age 19-44, right-handed (assessed using the Edinburgh Handedness Inventory, speak and understand English.

Exclusion Criteria:

1. Chili allergies
2. History of chronic pain or current acute pain
3. Present or previous neurologic such as epilepsy, Alzheimer disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumours and head trauma.
4. Present or previous musculoskeletal disorders such muscle/tendon strain, ligament sprain tension,tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
5. Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
6. Pregnancy
7. Current use of medications that may affect the trial (e.g. pain relieving medication and anti-inflammatory medication)
8. Using hair products that may interfere with EEG conductance such as gel, except for shampoo, prior to the trial.
9. Drug addiction defined as the use of cannabis, opioids or other drugs
10. Consumption of alcohol, caffeine, or tobacco 6 hours before the experimental onset
11. Lack of ability to cooperate -

Primary outcomes:
measure: Change in resting state functional connectivity
timeFrame: Granger causality is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, 24 hours, cooling at 24hours, and heating at 24 hours.
measure: Change in Subjective pain intensity
timeFrame: Intensity is assessed at 5 time points for each condition (capsaicin or placebo): baseline, 1 hour, 24 hours, cooling at 24hours, and heating at 24 hours.
Secondary outcomes:
measure: Change in Pain sensitivity (Warmth detection threshold)
timeFrame: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
measure: Change in Pain sensitivity ( Cold detection threshold).
timeFrame: Warmth detection threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
measure: Change in Pain sensitivity ( Heat pain threshold).
timeFrame: Heat pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
measure: Change in Pain sensitivity ( Cold pain thresholds).
timeFrame: Cold pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
measure: Change in Pain sensitivity ( Mechanical pain thresholds).
timeFrame: Mechanical pain threshold is assessed at 3 time points for each condition (capsaicin or placebo): baseline, 1 hour, and 24 hours.
measure: Pain vigilance
timeFrame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
measure: Pain Catastrophizing
timeFrame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
measure: Sleep quality assessment
timeFrame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
measure: Fatigue assessment
timeFrame: It is assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
measure: Positive and negative affect
timeFrame: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
measure: Depression scores
timeFrame: They are assessed at baseline and after 24 hours for each condition (capsaicin or placebo).
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University, Department of Health Sciences and technology
Study officials:
affiliation: Aalborg University
name: Thomas Graven-Nielsen, DMSc, PhD
role: STUDY_DIRECTOR
References: