HealthyNCT06197529

Is Nociceptive Processing Evoked by Heat Homeostatically Regulated: A Contact-heat Evoked Potentials Study

A study testing Homeostatic Plasticity and Topical alone (Capsaicin 8% Patch) in people with Healthy, run by Aalborg University at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Homeostatic plasticity is a mechanism that stabilizes neuronal activity to prevent excessive nervous system excitability. This mechanism can be investigated in humans by applying two blocks of non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Homeostatic Plasticity and Topical alone (Capsaicin 8% Patch)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteDenmark
Study dates: 21 Nov 2023to 4 Mar 2024
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 right-handed men and women aged 18-60 years
Speak, read, and understand English or Danish

Who cannot join

Pregnant, breastfeeding, or women in childbearing age not using contraceptive methods
Regular use of cannabis, opioids or other drugs (except contraceptives)
Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g. brain or spinal cord injuries, degenerative neurological disorders, epilepsy, major depression, cardiovascular disease, chronic lung disease, etc.)
Current or previous chronic or recurrent pain condition (other than low back pain in patients recruited for sub-project 6, and this item does not apply to sub-project 8)
Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs) For subproject 8, chronic low back pain patients may take analgesic medication provided the dosage is stable
Open wounds, eczema, scars, or tattoos in the area of the heat stimulation (sub-project 1)

Show all 12Show fewer

Lack of ability to cooperate
Recent history of acute pain particularly in the lower limbs (unless related to low back pain in patients included in sub-project 6 or 8)
Abnormally disrupted sleep in 24 hours preceding experiment
Any medical or other condition (i.e. musculoskeletal, cardiorespiratory, neurological, etc.)
Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
Unable to answer to the "Transcranial Magnetic Stimulation Adult Safety Screen" or tDCS screening questionnaire (see Bilag_v1_06092021)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Aalborg University / Center for Neuroplasticity and Pain
Gistrup, 9260

Other trials in Denmark

About this study

In healthy subjects, homeostatic plasticity induction over the primary motor cortex increases the amplitude of motor-evoked potentials after the first block of excitatory tDCS, which then decreases after the second block of excitatory tDCS. However, this mechanism is impaired in chronic and experimental pain, demonstrated by an increase in excitability instead of a reversal.

The role of homeostatic plasticity mechanisms in pain is yet to be unraveled, but homeostatic plasticity may hold an important role in pain development or persistence.

Thus, the aim of this study is to investigate if the cortical nociceptive response reflected by contact heat stimulation (CHEPs) is regulated by homeostatic mechanisms. For this, homeostatic plasticity will be induced in both the primary motor (M1) and sensory cortices (S1). The first research question will explore if the contact heat evoked potentials are homeostatically regulated and if this regulation is occurring locally or globally in the cortex. Additionally, it will be investigated if and how capsaicin-induced nociception interacts and effects the homeostatic response as reflected by CHEPs.

Read the detailed description

Randomized, cross-over study of four sessions

Conditions: Healthy
Being tested: Homeostatic Plasticity, Topical alone (Capsaicin 8% Patch), Placebo Patch, Homeostatic Plasticity (Sham)
Keywords: Homeostatic Plasticity, Capsaicin, Transcranial Direct Current Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Homeostatic PlasticityOther
Anodal tDCS S1/M1
Topical alone (Capsaicin 8% Patch)Drug
Also called Qutenza Capsaicin (8%)
4x4 patch
Placebo PatchOther
4x4 patch
Homeostatic Plasticity (Sham)Other
sham Homeostatic Plasticity protocol over S1

Study groups in NCT06197529
Study group	Role	What they receive
S1 Homeostatic Plasticity-Pain	Experimental	Anodal tDCS CP3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand Receives: Other: Homeostatic Plasticity; Drug: Topical alone (Capsaicin 8% Patch)
S1 Homeostatic Plasticity-NoPain	Placebo comparator	Anodal tDCS C3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand Receives: Other: Homeostatic Plasticity; Other: Placebo Patch
S1 Homeostatic Plasticity-Sham	Sham comparator	Sham tDCS C3 FP2 4x4 patch on the dorsum of the hand Receives: Other: Placebo Patch; Other: Homeostatic Plasticity (Sham)
M1 Homeostatic Plasticity	Active comparator	Anodal tDCS C3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand Receives: Other: Homeostatic Plasticity; Other: Placebo Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Contact Heat Evoked Potentials
Baseline (Evoked Potentials after stimulus onset from electroencephalographic channels)
Measured: Pre-patch application
Contact Heat Evoked Potentials
Post-Patch (Evoked Potentials after stimulus onset from electroencephalographic channels)
Measured: 30 minutes after patch application
Contact Heat Evoked Potentials
Post-Priming (Evoked Potentials after stimulus onset from electroencephalographic channels)
Measured: During the homeostatic plasticity protocol - 0 minutes after the first block of anodal tDCS
Contact Heat Evoked Potentials
Post-HP (Evoked Potentials after stimulus onset from electroencephalographic channels)
Measured: 0 minutes after homeostatic plasticity induction
Contact Heat Evoked Potentials
Post-HP+10 minutes (Evoked Potentials after stimulus onset from electroencephalographic channels)
Measured: 10 minutes after the homeostatic plasticity protocol

Secondary outcomes (16)

Pain Intensity After Stimulation Blocks (0-10)
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: 0 minutes after the first block of CHEP stimulation
Pain Intensity After Stimulation Blocks (0-10)
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: 0 minutes after the second block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: 0 minutes after the third block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: 0 minutes after the fourth block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: 0 minutes after the fifth block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Measured with a calibrated brush for the study of dynamic mechanical allodynia (Brush-05®, Somedic SenseLab AB, Sösdala, Sweden)
Measured: 0 minutes after the first block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Measured with a calibrated brush for the study of dynamic mechanical allodynia (Brush-05®, Somedic SenseLab AB, Sösdala, Sweden)
Measured: 0 minutes after the second block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Measured with a calibrated brush for the study of dynamic mechanical allodynia (Brush-05®, Somedic SenseLab AB, Sösdala, Sweden)
Measured: 0 minutes after the third block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Measured with a calibrated brush for the study of dynamic mechanical allodynia (Brush-05®, Somedic SenseLab AB, Sösdala, Sweden)
Measured: 0 minutes after the fourth block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Measured with a calibrated brush for the study of dynamic mechanical allodynia (Brush-05®, Somedic SenseLab AB, Sösdala, Sweden)
Measured: 0 minutes after the fifth block of CHEP stimulation
Pittsburg Sleeping Quality Index
The global PSQI score ranges from 0 to 21, calculated by adding seven component scores. A global score above 5 (PSQI > 5) indicates relevant sleep disturbances or poor sleep quality (Buysse et al., 1989).
Measured: Pre-intervention and pre-patch application
BECKS Depression Inventory
The questionnaire includes 21 items which are rated on a 4-point scale (0 to 3). The total score is calculated by adding all items. Total score values from 0-13 indicate "normal ups and downs", and scores between 14-19, 20-28, and 29-63, are interpreted as mild, moderate, and severe symptoms (Beck et al., 1996; Goldstein et al., 2013; Wang and Gorenstein, 2013).
Measured: Pre-intervention and pre-patch application
Positive and Negative Affective Schedule - Short Form
Scores can range from 10 - 50, with higher scores representing higher levels of positive/negative affect.
Measured: Pre-intervention and pre-patch application
State-Trait Anxiety Inventory
A 40-item questionnaire that assesses state and trait anxiety with 20 items each (Skapinakis, 2014; Spielberger et al., 1983). Each subscale (S-Anxiety and T-Anxiety) uses a 4-point Linkert scale ranging from 1 ("not at all" for S- or "almost never" for T-Anxiety) to 4 ("very much so" for S- and "almost always" for T-Anxiety). A higher scole indicates more severe anxiety with a range from 20-80.
Measured: Pre-intervention and pre-patch application
Pain Catastrophizing Scale
This questionnaire assesses 13 items describing different thoughts and feelings which may be associated with pain. They are rated on a 5-point scale (0-5) indicating the degree to which these thoughts and feelings are present when having pain. The total score is 0-52, with a higher score indicating a higher pain catastrophizing. (Sullivan M J L, Bishop S, Pivik J. 1995)
Measured: Pre-intervention and pre-patch application
Pain intensity (Induced by Capsaicin)
Pain intensity measured using an 11-point numeric rating scale where 0= no pain and 10 = worst imaginable pain
Measured: Throughout the experimental session, every 5 minutes and up to 55 minutes after patch application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20234 Mar 2024

First posted9 Jan 2024
Study start21 Nov 2023
Primary completion4 Mar 2024
Study completion4 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06197529
Sponsor's protocol ID: CHEPS-DMZ-CNAP
Status last verified: May 2024
First submitted: 22 Nov 2023
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data will not be available online, but the data collected can be shared upon reasonable request.

Publications

Wittkopf PG, Larsen DB, Gregoret L, Graven-Nielsen T. Prolonged corticomotor homeostatic plasticity - Effects of different protocols and their reliability. Brain Stimul. 2021 Mar-Apr;14(2):327-329. doi: 10.1016/j.brs.2021.01.017. Epub 2021 Jan 24. No abstract available.
PubMed 33503491
Wittkopf PG, Larsen DB, Graven-Nielsen T. Protocols for inducing homeostatic plasticity reflected in the corticospinal excitability in healthy human participants: A systematic review and meta-analysis. Eur J Neurosci. 2021 Aug;54(4):5444-5461. doi: 10.1111/ejn.15389. Epub 2021 Jul 30.
PubMed 34251703
Wittkopf PG, Boye Larsen D, Gregoret L, Graven-Nielsen T. Disrupted Cortical Homeostatic Plasticity Due to Prolonged Capsaicin-induced Pain. Neuroscience. 2023 Nov 21;533:1-9. doi: 10.1016/j.neuroscience.2023.09.011. Epub 2023 Sep 27.
PubMed 37774909
Thapa T, Graven-Nielsen T, Schabrun SM. Aberrant plasticity in musculoskeletal pain: a failure of homeostatic control? Exp Brain Res. 2021 Apr;239(4):1317-1326. doi: 10.1007/s00221-021-06062-3. Epub 2021 Feb 26.
PubMed 33635391
Thapa T, Graven-Nielsen T, Chipchase LS, Schabrun SM. Disruption of cortical synaptic homeostasis in individuals with chronic low back pain. Clin Neurophysiol. 2018 May;129(5):1090-1096. doi: 10.1016/j.clinph.2018.01.060. Epub 2018 Feb 9.
PubMed 29472134
Lejeune N, Petrossova E, Frahm KS, Mouraux A. High-speed heating of the skin using a contact thermode elicits brain responses comparable to CO2 laser-evoked potentials. Clin Neurophysiol. 2023 Feb;146:1-9. doi: 10.1016/j.clinph.2022.11.008. Epub 2022 Nov 24.
PubMed 36473333
Lenoir C, Algoet M, Mouraux A. Deep continuous theta burst stimulation of the operculo-insular cortex selectively affects Adelta-fibre heat pain. J Physiol. 2018 Oct;596(19):4767-4787. doi: 10.1113/JP276359. Epub 2018 Sep 4.
PubMed 30085357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is Nociceptive Processing Evoked by Heat Homeostatically Regulated: A Contact-heat Evoked Potentials Study
ClinicalTrials.gov ID: NCT06197529
Acronym / sponsor ID: CHEPS-DMZ-CNAP
Conditions: Healthy
Keywords: Homeostatic Plasticity, Capsaicin, Transcranial Direct Current Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Aalborg UniversityUniversity, hospital or other
Study start: 21 Nov 2023 (actual)
Primary completion: 4 Mar 2024 (actual)
Study completion: 4 Mar 2024 (actual)
First posted: 9 Jan 2024 (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.

The role of homeostatic plasticity mechanisms in pain is yet to be unraveled, but homeostatic plasticity may hold an important role in pain development or persistence.

Detailed description

Randomized, cross-over study of four sessions

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
S1 Homeostatic Plasticity-Pain	Experimental	Other: Homeostatic Plasticity, Drug: Topical alone (Capsaicin 8% Patch)Anodal tDCS CP3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand
S1 Homeostatic Plasticity-NoPain	Placebo comparator	Other: Homeostatic Plasticity, Other: Placebo PatchAnodal tDCS C3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand
S1 Homeostatic Plasticity-Sham	Sham comparator	Other: Placebo Patch, Other: Homeostatic Plasticity (Sham)Sham tDCS C3 FP2 4x4 patch on the dorsum of the hand
M1 Homeostatic Plasticity	Active comparator	Other: Homeostatic Plasticity, Other: Placebo PatchAnodal tDCS C3 1mA FP2 -1mA 4x4 patch on the dorsum of the hand

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy right-handed men and women aged 18-60 years
Speak, read, and understand English or Danish

Key exclusion criteria (12 listed)

Pregnant, breastfeeding, or women in childbearing age not using contraceptive methods
Regular use of cannabis, opioids or other drugs (except contraceptives)
Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g. brain or spinal cord injuries, degenerative neurological disorders, epilepsy, major depression, cardiovascular disease, chronic lung disease, etc.)
Current or previous chronic or recurrent pain condition (other than low back pain in patients recruited for sub-project 6, and this item does not apply to sub-project 8)
Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs) For subproject 8, chronic low back pain patients may take analgesic medication provided the dosage is stable

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
Homeostatic PlasticityAnodal tDCS S1/M1	Other	M1 Homeostatic Plasticity, S1 Homeostatic Plasticity-NoPain, S1 Homeostatic Plasticity-Pain
Topical alone (Capsaicin 8% Patch)Also: Qutenza Capsaicin (8%)4x4 patch	Drug	S1 Homeostatic Plasticity-Pain
Placebo Patch4x4 patch	Other	M1 Homeostatic Plasticity, S1 Homeostatic Plasticity-NoPain, S1 Homeostatic Plasticity-Sham
Homeostatic Plasticity (Sham)sham Homeostatic Plasticity protocol over S1	Other	S1 Homeostatic Plasticity-Sham

Primary outcome

Contact Heat Evoked Potentials
Time frame: Pre-patch application
Baseline (Evoked Potentials after stimulus onset from electroencephalographic channels)
Contact Heat Evoked Potentials
Time frame: 30 minutes after patch application
Post-Patch (Evoked Potentials after stimulus onset from electroencephalographic channels)
Contact Heat Evoked Potentials
Time frame: During the homeostatic plasticity protocol - 0 minutes after the first block of anodal tDCS
Post-Priming (Evoked Potentials after stimulus onset from electroencephalographic channels)
Contact Heat Evoked Potentials
Time frame: 0 minutes after homeostatic plasticity induction
Post-HP (Evoked Potentials after stimulus onset from electroencephalographic channels)
Contact Heat Evoked Potentials
Time frame: 10 minutes after the homeostatic plasticity protocol
Post-HP+10 minutes (Evoked Potentials after stimulus onset from electroencephalographic channels)

16 secondary outcomes

Pain Intensity After Stimulation Blocks (0-10)
Time frame: 0 minutes after the first block of CHEP stimulation
Pain Intensity After Stimulation Blocks (0-10)
Time frame: 0 minutes after the second block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Time frame: 0 minutes after the third block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Time frame: 0 minutes after the fourth block of CHEP stimulation
Pain Intensity After Stimulation Blocks
Time frame: 0 minutes after the fifth block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Time frame: 0 minutes after the first block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Time frame: 0 minutes after the second block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Time frame: 0 minutes after the third block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Time frame: 0 minutes after the fourth block of CHEP stimulation
Presence of Allodynia After Stimulation Blocks
Time frame: 0 minutes after the fifth block of CHEP stimulation
Pittsburg Sleeping Quality Index
Time frame: Pre-intervention and pre-patch application
BECKS Depression Inventory
Time frame: Pre-intervention and pre-patch application
Positive and Negative Affective Schedule - Short Form
Time frame: Pre-intervention and pre-patch application
State-Trait Anxiety Inventory
Time frame: Pre-intervention and pre-patch application
Pain Catastrophizing Scale
Time frame: Pre-intervention and pre-patch application
Pain intensity (Induced by Capsaicin)
Time frame: Throughout the experimental session, every 5 minutes and up to 55 minutes after patch application

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 16 May 2024.
Background: PubMed 33503491Wittkopf PG, Larsen DB, Gregoret L, Graven-Nielsen T. Prolonged corticomotor homeostatic plasticity - Effects of different protocols and their reliability. Brain Stimul. 2021 Mar-Apr;14(2):327-329. doi: 10.1016/j.brs.2021.01.017. Epub 2021 Jan 24. No abstract available.
Background: PubMed 34251703Wittkopf PG, Larsen DB, Graven-Nielsen T. Protocols for inducing homeostatic plasticity reflected in the corticospinal excitability in healthy human participants: A systematic review and meta-analysis. Eur J Neurosci. 2021 Aug;54(4):5444-5461. doi: 10.1111/ejn.15389. Epub 2021 Jul 30.
Background: PubMed 37774909Wittkopf PG, Boye Larsen D, Gregoret L, Graven-Nielsen T. Disrupted Cortical Homeostatic Plasticity Due to Prolonged Capsaicin-induced Pain. Neuroscience. 2023 Nov 21;533:1-9. doi: 10.1016/j.neuroscience.2023.09.011. Epub 2023 Sep 27.
Background: PubMed 33635391Thapa T, Graven-Nielsen T, Schabrun SM. Aberrant plasticity in musculoskeletal pain: a failure of homeostatic control? Exp Brain Res. 2021 Apr;239(4):1317-1326. doi: 10.1007/s00221-021-06062-3. Epub 2021 Feb 26.
Background: PubMed 29472134Thapa T, Graven-Nielsen T, Chipchase LS, Schabrun SM. Disruption of cortical synaptic homeostasis in individuals with chronic low back pain. Clin Neurophysiol. 2018 May;129(5):1090-1096. doi: 10.1016/j.clinph.2018.01.060. Epub 2018 Feb 9.
Background: PubMed 36473333Lejeune N, Petrossova E, Frahm KS, Mouraux A. High-speed heating of the skin using a contact thermode elicits brain responses comparable to CO2 laser-evoked potentials. Clin Neurophysiol. 2023 Feb;146:1-9. doi: 10.1016/j.clinph.2022.11.008. Epub 2022 Nov 24.
Background: PubMed 30085357Lenoir C, Algoet M, Mouraux A. Deep continuous theta burst stimulation of the operculo-insular cortex selectively affects Adelta-fibre heat pain. J Physiol. 2018 Oct;596(19):4767-4787. doi: 10.1113/JP276359. Epub 2018 Sep 4.
Individual participant dataSharing planned: No. The individual participant data will not be available online, but the data collected can be shared upon reasonable request.

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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.

Thomas Graven-Nielsen, PhD, DMSc study director

Aalborg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Homeostatic Plasticity and Topical alone (Capsaicin 8% Patch) in people with Healthy, 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 12 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 16 May 2024. 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. Some participants in this study may receive a placebo. 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?

Contact Heat Evoked Potentials (time frame: Pre-patch application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06197529, which also lists 7 linked publications.

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 16 May 2024.