NCT05566444

Brief Summary

This study investigates the modification of the local-to-global connectivity pattern in response to experimental heat pain. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity to TMS. A thermal cutaneous heat stimulus will induce painful sensations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 27, 2022

Last Update Submit

January 25, 2023

Conditions

HeatPainElectroencephalographyTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Cortical connectivity

    Global and local mean field amplitude

    Reduced cortical connectivity (more local) during heat pain. Changes will be investigated before and after heat pain (1 hour)

Secondary Outcomes (1)

  • Cortical excitability

    Reduced cortical excitability during heat pain. Changes will be investigated before and after heat pain (1 hour)

Study Arms (1)

Experimental heat pain

EXPERIMENTAL

For each participant, we will collect TMS-EEG responses in 4 conditions: 1) Baseline, 2) Heat pain; 3) warm sensation; 4) post-pain.

Device: Heat stimulus

Interventions

Heat stimulusDEVICE

Contact heat pain stimulus with a termode set at 46 degrees and contact warm stimulus with a termode set at 40 degrees

Experimental heat pain

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Speak and understand English

You may not qualify if:

  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • History of chronic pain or current acute pain
  • Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
  • Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enrico De Martino

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Dr

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 4, 2022

Study Start

October 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 24, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

DK(1)