Marsili SyndromeNCT07755930
Marsili Syndrome as a Gateway to Novel Analgesic Targets
A study testing Histamine, Cowhage (Mucuna Pruriens) and Capsaicin 8% Patch in people with Marsili Syndrome, run by Aalborg University at 1 site in Denmark.
Trial summary
Congenital insensitivity to pain (CIP) comprises a group of rare genetic disorders caused by mutations in genes essential for pain sensing in humans. Among these, Marsili syndrome is caused by a dominant point mutation in the transcription factor ZFHX2, and it is characterized by markedly reduced sensitivity to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Marsili Syndrome
- What is being tested?
- Histamine, Cowhage (Mucuna Pruriens) and Capsaicin 8% Patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 18-80 years
- Marsili syndrome
- Speak and understand English
Who cannot join
- Pregnant or breastfeeding
- Current regular use of cannabis, opioids, cocaine, amphetamines, MDMA/ecstasy, benzodiazepines, barbiturates, hallucinogens, or other central nervous system-active recreational drugs.
- Current use of prescription medication that may significantly affect pain perception, itch perception, cortical excitability, or inflammatory responses, including opioids, antiepileptic drugs, antidepressants, antipsychotics, systemic corticosteroids, or immunosuppressive medication.
- Current or previous neurological disease, including epilepsy, stroke, traumatic brain injury, spinal cord injury, multiple sclerosis, Parkinson's disease, or other degenerative neurological disorders.
- Current or previous severe psychiatric disorder, including major depression, psychosis, bipolar disorder, or severe anxiety disorder.
- Current or previous clinically significant musculoskeletal, cardiovascular, pulmonary, inflammatory, autoimmune, or dermatological disease that may interfere with study procedures or outcome measures.
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- Lack of ability to understand study information, provide informed consent, or cooperate with study procedures.
- Abnormally disrupted sleep during the 24 hours before the experiment.
- Contraindications to TMS, including previous epileptic seizure, implanted electronic medical devices, metal implants in the head or jaw, implanted hearing aids, facial metal implants, permanent makeup, or tattoos in the facial area.
- Inability to pass the Transcranial Magnetic Stimulation Adult Safety Screen.
- Abnormally disrupted sleep in the 24 hours preceding the experiment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Gistrup, Aalborg, 9260
Silvia Lo Vecchio, 21397785 ext. 0045, slv@hst.aau.dk
About this study
Congenital insensitivity to pain (CIP) comprises a group of rare genetic disorders caused by mutations in genes essential for pain sensing in humans. Among these, Marsili syndrome is caused by a dominant point mutation in the transcription factor ZFHX2, and it is characterized by markedly reduced sensitivity to noxious heat, mechanical injury, while other functions remain intact. this project aims to establish the first integrated, system-level characterization of Marsili syndrome by combining human sensory phenotyping with neurophysiological and molecular analyses. The study will be conducted in two sessions of approximately 4 hours each, 24 hours apart from each other
- Conditions
- Marsili Syndrome
- Being tested
- Histamine, Cowhage (Mucuna Pruriens), Capsaicin 8% Patch, Knee Injections of hypertonic saline, Cold Pressure Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistamineOther
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
Cowhage (Mucuna Pruriens)Other
The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm
Capsaicin 8% PatchDrug
Capsaicin patches (2x2 cm, dosage form: transdermal patch 8%) will be applied on the selected area. The patch will be left in place for 30 minutes after which it will be removed.
Knee Injections of hypertonic salineOther
Experimental knee pain will be induced with a 0.25-0.30 mL bolus injection of 5% hypertonic saline, which will be injected into the dominant Infrapatellar Fat Pad (IFP)
Cold Pressure TestOther
Participants will be asked to place their hand in the cold-water tank (temperature around 5°C) and to keep it for as long as they can tolerate it.
Computerized Conditioned Pain Modulation (CPM)Other
CPM will be assessed using a double-cuff.
| Study group | Role | What they receive |
|---|---|---|
| Marsili group | Experimental | Not described Receives: Other: Histamine; Other: Cowhage (Mucuna Pruriens); Drug: Capsaicin 8% Patch; Other: Knee Injections of hypertonic saline; Other: Cold Pressure Test; Other: Computerized Conditioned Pain Modulation (CPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring pain by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a scale from 0 to100, where 0 represents no pain and 100 represent the worst imaginable pain.
Measured: Day 1
Measuring pain by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a scale from 0 to100, where 0 represents no pain and 100 represent the worst imaginable pain.
Measured: Day 2
Measuring Itch by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a scale from 0 to100, where 0 represents no itch and 100 represent the worst imaginable itch.
Measured: Day 1
Measuring Itch by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a scale from 0 to100, where 0 represents no itch and 100 represent the worst imaginable itch.
Measured: Day 2
Alloknesis
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: Day 1
Alloknesis
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: Day 2
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: Day 1
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: Day 2
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 1
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 2
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 2
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 1
Pressure Pain Threshold
Pressure pain threshold (PPT) is obtained using a manual pressure algometer
Measured: Day 1
Pressure Pain Threshold
Pressure pain threshold (PPT) is obtained using a manual pressure algometer
Measured: Day 2
Mechanical Suprathreshold Pain Stimulation
Once PPT has been determined, stimuli of 130% of the PPT will be delivered to the limb or shoulder to create a sensation of subjective mild/moderate pain
Measured: Day 2
Computerized Cuff Pressure Algometer (CPA)
A computer-controlled cuff pressure algometer works by inflating a cuff/tourniquet, which is similar in design to those used for measuring blood pressure
Measured: Day 1
Spatial and Temporal Summation of Pain
Spatial and temporal summation of pain will be assessed with the use of the computerized cuff pressure algometer
Measured: Day 1
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
EEG recording
The EEG signal will be acquired constantly through 64 electrodes placed on the scalp according to the international 10-20 system with a standard EEG cap
Measured: Day 1
Measuring cortical responses to magnetic stimulation
Transcranial magnetic stimulation (TMS) will be used to evoke cortical responses (TMSevoked potentials - TEPs) in the left and right motor cortex with a figure-eight-shaped cone coil (200 pulses for each target).
Measured: Day 1
Secondary outcomes (15)
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 1
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 2
Pain Catastrophizing Scale (PCS).
The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
Measured: Baseline
Itch Catastrophizing Scale (ICS).
The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
Measured: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
The RST-PQ contains in total, 65 items must be answered on a 4-point Likert-type scale
Measured: Baseline
Depression, Anxiety, Stress Scale (DASS-21)
The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much"
Measured: Baseline
Learned Helplessness Scale (LHS)
The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4).
Measured: Baseline
Positive And Negative Affect Schedule (PANAS)
Twenty words are associated with the subject's current feelings and have to be rated on a 5-points Likert-type scale, whit 0 corresponding to "not at all" and 5 corresponding to "Very".
Measured: Baseline
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
The questionnaire is an 18-item measure used to identify emotional regulation issues in adults. Participants rate each item on a 5-point Likert scale (from 1 to 5).
Measured: Baseline
Emotion Regulation Questionnaire (ERQ)
This questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), where 4 means (neutral).
Measured: Baseline
The Pittsburg Sleep Quality Index (PSQI)
Consists of seven scored from zero to 21 with higher scores reflecting a worse overall quality o: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Baseline
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
MAIA-2 consists of 37 self-report items that evaluates multiple dimensions of interoception, distinguishing between simple detection of bodily signals and the cognitive-affective interpretation of those signals.
Measured: Baseline
Body Perception Questionnaire (BPQ-SF)
BPQ-SF consists of 12 self-report items designed to assess the frequency and intensity of perceived autonomic and somatic bodily sensations.
Measured: Baseline
The International Physical Activity Questionnaire (IPAQ)
IPAQ is a standardized self-report instrument developed to assess habitual physical activity levels
Measured: Baseline
Mediterranean Diet Adherence Screener (MEDAS)
MEDAS is a validated 14-point questionnaire to evaluate dietary habits
Measured: Baseliene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marsili SyndromeStudies 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
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755930
- Sponsor's protocol ID
- N-20260041
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marsili Syndrome as a Gateway to Novel Analgesic Targets
- ClinicalTrials.gov ID
- NCT07755930
- Acronym / sponsor ID
- N-20260041
- Conditions
- Marsili Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Aug 2026 (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.
Congenital insensitivity to pain (CIP) comprises a group of rare genetic disorders caused by mutations in genes essential for pain sensing in humans. Among these, Marsili syndrome is caused by a dominant point mutation in the transcription factor ZFHX2, and it is characterized by markedly reduced sensitivity to noxious heat, mechanical injury, while other functions remain intact. this project aims to establish the first integrated, system-level characterization of Marsili syndrome by combining human sensory phenotyping with neurophysiological and molecular analyses. The study will be conducted in two sessions of approximately 4 hours each, 24 hours apart from each other
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marsili group | Experimental | Other: Histamine, Other: Cowhage (Mucuna Pruriens), Drug: Capsaicin 8% Patch, Other: Knee Injections of hypertonic saline, Other: Cold Pressure Test, Other: Computerized Conditioned Pain Modulation (CPM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women aged 18-80 years
- Marsili syndrome
- Speak and understand English
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Current regular use of cannabis, opioids, cocaine, amphetamines, MDMA/ecstasy, benzodiazepines, barbiturates, hallucinogens, or other central nervous system-active recreational drugs.
- Current use of prescription medication that may significantly affect pain perception, itch perception, cortical excitability, or inflammatory responses, including opioids, antiepileptic drugs, antidepressants, antipsychotics, systemic corticosteroids, or immunosuppressive medication.
- Current or previous neurological disease, including epilepsy, stroke, traumatic brain injury, spinal cord injury, multiple sclerosis, Parkinson's disease, or other degenerative neurological disorders.
- Current or previous severe psychiatric disorder, including major depression, psychosis, bipolar disorder, or severe anxiety disorder.
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 |
|---|---|---|
| HistamineTo deliver histamine, standard allergy skin prick test (SPT) lancets are applied | Other | Marsili group |
| Cowhage (Mucuna Pruriens)The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm | Other | Marsili group |
| Capsaicin 8% PatchCapsaicin patches (2x2 cm, dosage form: transdermal patch 8%) will be applied on the selected area. The patch will be left in place for 30 minutes after which it will be removed. | Drug | Marsili group |
| Knee Injections of hypertonic salineExperimental knee pain will be induced with a 0.25-0.30 mL bolus injection of 5% hypertonic saline, which will be injected into the dominant Infrapatellar Fat Pad (IFP) | Other | Marsili group |
| Cold Pressure TestParticipants will be asked to place their hand in the cold-water tank (temperature around 5°C) and to keep it for as long as they can tolerate it. | Other | Marsili group |
| Computerized Conditioned Pain Modulation (CPM)CPM will be assessed using a double-cuff. | Other | Marsili group |
Primary outcome
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 1
We will ask the subjects to rate the sensation of pain on a scale from 0 to100, where 0 represents no pain and 100 represent the worst imaginable pain.
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 2
We will ask the subjects to rate the sensation of pain on a scale from 0 to100, where 0 represents no pain and 100 represent the worst imaginable pain.
Measuring Itch by computerized Visual Analog Scale Scoring
Time frame: Day 1
We will ask the subjects to rate the sensation of itch on a scale from 0 to100, where 0 represents no itch and 100 represent the worst imaginable itch.
Measuring Itch by computerized Visual Analog Scale Scoring
Time frame: Day 2
We will ask the subjects to rate the sensation of itch on a scale from 0 to100, where 0 represents no itch and 100 represent the worst imaginable itch.
Alloknesis
Time frame: Day 1
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Alloknesis
Time frame: Day 2
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Mechanically evoked itch (MEI)
Time frame: Day 1
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Mechanically evoked itch (MEI)
Time frame: Day 2
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Mechanical Pain Thresholds (MPT)
Time frame: Day 1
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Mechanical Pain Thresholds (MPT)
Time frame: Day 2
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Mechanical Pain Sensitivity (MPS)
Time frame: Day 2
This test is conducted with the same pinprick set used to test the MPT.
Mechanical Pain Sensitivity (MPS)
Time frame: Day 1
This test is conducted with the same pinprick set used to test the MPT.
Pressure Pain Threshold
Time frame: Day 1
Pressure pain threshold (PPT) is obtained using a manual pressure algometer
Pressure Pain Threshold
Time frame: Day 2
Pressure pain threshold (PPT) is obtained using a manual pressure algometer
Mechanical Suprathreshold Pain Stimulation
Time frame: Day 2
Once PPT has been determined, stimuli of 130% of the PPT will be delivered to the limb or shoulder to create a sensation of subjective mild/moderate pain
Computerized Cuff Pressure Algometer (CPA)
Time frame: Day 1
A computer-controlled cuff pressure algometer works by inflating a cuff/tourniquet, which is similar in design to those used for measuring blood pressure
Spatial and Temporal Summation of Pain
Time frame: Day 1
Spatial and temporal summation of pain will be assessed with the use of the computerized cuff pressure algometer
Cold Detection Thresholds (CDT)
Time frame: Day 1
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Detection Thresholds (CDT)
Time frame: Day 2
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Warm Detection Thresholds (WDT)
Time frame: Day 1
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Warm Detection Thresholds (WDT)
Time frame: Day 2
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Pain Thresholds (CPT)
Time frame: Day 1
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Pain Thresholds (CPT)
Time frame: Day 2
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Heat Pain Thresholds (HPT)
Time frame: Day 1
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Heat Pain Thresholds (HPT)
Time frame: Day 2
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 1
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 2
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
EEG recording
Time frame: Day 1
The EEG signal will be acquired constantly through 64 electrodes placed on the scalp according to the international 10-20 system with a standard EEG cap
Measuring cortical responses to magnetic stimulation
Time frame: Day 1
Transcranial magnetic stimulation (TMS) will be used to evoke cortical responses (TMSevoked potentials - TEPs) in the left and right motor cortex with a figure-eight-shaped cone coil (200 pulses for each target).
15 secondary outcomes
Superficial blood perfusion
Time frame: Day 1
Superficial blood perfusion
Time frame: Day 2
Pain Catastrophizing Scale (PCS).
Time frame: Baseline
Itch Catastrophizing Scale (ICS).
Time frame: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time frame: Baseline
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: Baseline
Learned Helplessness Scale (LHS)
Time frame: Baseline
Positive And Negative Affect Schedule (PANAS)
Time frame: Baseline
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time frame: Baseline
Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline
The Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time frame: Baseline
Body Perception Questionnaire (BPQ-SF)
Time frame: Baseline
The International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
Mediterranean Diet Adherence Screener (MEDAS)
Time frame: Baseliene
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histamine, Cowhage (Mucuna Pruriens) and Capsaicin 8% Patch in people with Marsili Syndrome, 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Lo Vecchio (21397785 ext. 0045, slv@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring pain by computerized Visual Analog Scale Scoring (time frame: Day 1). The study lists 29 primary outcomes in all. 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 10 Aug 2026.