TMS-EEG-heat: TMS-evoked Potentials During Heat Pain

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT05566444
Collaborator
(none)
24
1
1
3.8
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Heat stimulus
N/A

Detailed Description

Abnormal connectivity patterns interfere with the normal function of a given neuronal network, thus leading to circuit dysfunction and, subsequently, chronic pain. In the last few years, neuroscience has been heavily influenced by network science. This synergistic association provided a new framework for understanding brain function in health and how dysfunction in specific neuronal brain circuits can lead to symptoms. A network comprises nodes (e.g., areas of the brain) and edges (functional connections between nodes). An effective network can process and share large amounts of information while maintaining specificity and not allowing noise to contaminate the flow of information across the circuits. The network approach to brain functioning has been able to integrate what has been known for several decades as spatial structural anatomy with the time-varying streaming of information (connectivity) in a dynamic perspective. In this context, symptoms of diseases are seen as being correlated with specific network abnormalities, and therapeutic interventions as being associated with the normalisation of these abnormal patterns of connection. This study will investigate the responses of specific neuronal brain circuits to experimental heat pain in healthy volunteers. It has been hypothesised that the local-to-global connectivity pattern obtained by the stimulation of different cortical hubs (e.g., the primary motor and dorsolateral prefrontal cortices) will be described by TMS-EEG responses in healthy individuals, and the modification in cortical connectivity in experimental models will be described and compared it with a non-painful sensory stimulation of the same salience.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Heat-evoked Experimental Pain on Brain Connectivity
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Jan 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental heat pain

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

Outcome Measures

Primary Outcome Measures

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

    Global and local mean field amplitude

Secondary Outcome Measures

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

    TMS-evoked potentials

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy men and women

  • Speak and understand English

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Enrico De Martino Aalborg Denmark 9000

Sponsors and Collaborators

  • Aalborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enrico De Martino, Dr, Aalborg University
ClinicalTrials.gov Identifier:
NCT05566444
Other Study ID Numbers:
  • N-20220018
First Posted:
Oct 4, 2022
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 26, 2023