HeatTMS-EEG-heatNCT05566444
TMS-evoked Potentials During Heat Pain
A study testing Heat stimulus in people with Heat and Pain, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat, Pain, Electroencephalography
- What is being tested?
- Heat stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Speak and understand English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Heat-evoked Experimental Pain on Brain Connectivity
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.
Read the 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.
- Conditions
- Heat, Pain, Electroencephalography, Transcranial Magnetic Stimulation
- Being tested
- Heat stimulus
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat stimulusDevice
Contact heat pain stimulus with a termode set at 46 degrees and contact warm stimulus with a termode set at 40 degrees
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Heat stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical connectivity
Global and local mean field amplitude
Measured: Reduced cortical connectivity (more local) during heat pain. Changes will be investigated before and after heat pain (1 hour)
Secondary outcomes (1)
Cortical excitability
TMS-evoked potentials
Measured: Reduced cortical excitability during heat pain. Changes will be investigated before and after heat pain (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2022
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566444
- Sponsor's protocol ID
- N-20220018
- Acronym
- TMS-EEG-heat
- Status last verified
- Jan 2023
- First submitted
- 27 Sep 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heat-evoked Experimental Pain on Brain Connectivity
- ClinicalTrials.gov ID
- NCT05566444
- Acronym / sponsor ID
- TMS-EEG-heat / N-20220018
- Conditions
- Heat, Pain, Electroencephalography, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental heat pain | Experimental | Device: Heat stimulusFor each participant, we will collect TMS-EEG responses in 4 conditions: 1) Baseline, 2) Heat pain; 3) warm sensation; 4) post-pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Speak and understand English
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat stimulusContact heat pain stimulus with a termode set at 46 degrees and contact warm stimulus with a termode set at 40 degrees | Device | Experimental heat pain |
Primary outcome
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
1 secondary outcome
Cortical excitability
Time frame: Reduced cortical excitability during heat pain. Changes will be investigated before and after heat pain (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat stimulus in people with Heat and Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical connectivity (time frame: Reduced cortical connectivity (more local) during heat pain. Changes will be investigated before and after heat pain (1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023; AzTrials last refreshed its copy on 29 Oct 2026.