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Completed

NCT Number: NCT05566444

TMS-evoked Potentials During Heat Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Enrico De Martino

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Heat stimulus

Device

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

Primary outcomes

  1. Cortical connectivity

    Time frame: 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 outcomes

  1. Cortical excitability

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

    TMS-evoked potentials

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Effects of Heat-evoked Experimental Pain on Brain Connectivity

Acronym: TMS-EEG-heat

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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