Measuring and Modulating Changes in EEG Resting State Functional Connectivity During Short-term and Long-term Pain

NCT ID: NCT05158309

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2021-11-06

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).

Conditions

Prolonged Pain, EEG, Resting State Functional Connectivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Capsaicin

Capsaicin condition: in this condition participants received pain using a (5x10 cm) 8% topical capsaicin patch on the volar part of the dominant right forearm.

Group Type: EXPERIMENTAL

8% Capsaicin patch

Intervention Type: OTHER

Cutaneous pain was induced using a (5x10 cm) 8% topical capsaicin patch (transdermal patch, 'Qutenza', Astellas) on the volar part of the dominant right forearm (5 cm from the wrist) of each participant.

Placebo

Placebo condition: participants received no pain.

Group Type: PLACEBO_COMPARATOR

placebo patch

Intervention Type: OTHER

A transparent patch with no formulation or effect but the same size of the capsaicin patch was applied to the same location.

Interventions

8% Capsaicin patch

Cutaneous pain was induced using a (5x10 cm) 8% topical capsaicin patch (transdermal patch, 'Qutenza', Astellas) on the volar part of the dominant right forearm (5 cm from the wrist) of each participant.

Intervention Type: OTHER

placebo patch

A transparent patch with no formulation or effect but the same size of the capsaicin patch was applied to the same location.

Intervention Type: OTHER

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 -

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish National Research Foundation

OTHER

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Najah Al Hajri

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Graven-Nielsen, DMSc, PhD

Role: STUDY_DIRECTOR

Aalborg University

Locations

Aalborg University, Department of Health Sciences and technology

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20190057

Identifier Type: -

Identifier Source: org_study_id