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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05566444
Other study ID # N-20220018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date January 24, 2023

Study information

Verified date January 2023
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 24, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Enrico De Martino Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cortical excitability TMS-evoked potentials Reduced cortical excitability during heat pain. Changes will be investigated before and after heat pain (1 hour)
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