ItchNCT06470737
Investigation of Corticospinal Excitability Aspects of Itch and Pain
A study testing Hypertonic Saline, Histamine and Cowhage in people with Itch and Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
The experiment consists of three experimental sessions conducted over a period of two weeks. In the first experimental session, we apply in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Hypertonic Saline, Histamine and Cowhage
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2024to 31 Oct 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 men and women
- 18-60 years
- Speak and understand English
Who cannot join
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder (e.g., heart stroke), or psychiatric diagnoses (e.g. depression) that may affect the results
- Current use of medications that may affect the trial, such as antihistamines, antipsychotics, and painkillers, as well as systemic or topical steroids
- Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
- Moles, scars, or tattoos in the area to be treated or tested.
Show all 13Show fewer
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Unable to pass the "Transcranial Magnetic Stimulation Adult Safety Screen" (subproject 1 and 2)
- Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.) (subproject 1 and 2)
- Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos (subproject 1 and 2)
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Neurophysiological and Psychological Aspects of Itch
The experiment consists of three experimental sessions conducted over a period of two weeks. In the first experimental session, we apply in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%). For 10 minutes after this, you are to assess the itch and pain you perceive. We will also apply non-invasive magnetic stimulations to your brain. During the experiment, you should fill in questionnaires. The second and third experimental sessions are conducted in the same way as the first session.
The purpose of this experiment is to investigate the changes appearing in the brain during artificially applied itch and pain corticomotor adaptations.
Read the detailed description
The experiment consists of three experimental sessions conducted over a period of two weeks. The duration of each session is approx. two hours. In the first experimental session, we apply one of three experimental methods in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%) Histamine is an itch-provoking substance formed in the human body. For 10 minutes after this, you are to assess the itch and pain you perceive on a scale from 0 to 10, in which 0 is no itch/pain and 10 is worst itch/pain imaginable. We will also apply non-invasive magnetic stimulations to your brain. This is done using a magnetic coil which is held over your head. During the experiment, you should fill in questionnaires about how you experience itch/pain and about your personality. The second and third experimental sessions are conducted in the same way as the first session. However, we will apply one of the other two experimental methods than the one used in the first session (i.e., first session: histamine, second session: plant needles, third session: injection with salt water). The experimental methods will be applied in random order.
- Being tested
- Hypertonic Saline, Histamine, Cowhage, Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Pruritus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic SalineOther
A bolus injection of hypertonic saline (7% NaCl) will be administered to the FDI muscle using a 1 mL syringe with a disposable needle (27G), and the volume of the bolus will be 0.2 mL
HistamineOther
A small drop of histamine dihydrochloride will be applied to a previously determined area on the volar forearm, followed by a prick through the drop
CowhageOther
This insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
Transcranial magnetic stimulation (TMS)Device
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Other: Hypertonic Saline; Other: Histamine; Other: Cowhage; Device: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scales (NRS)
NRS are essentially VAS but have tick marks spaced every centimeter so as to create 11-point scale (from 0 to 10). Subject can use these tick marks as a guide when they mark their severity on the scale.
Measured: 1 minute after every itch/pain induction
Measuring corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measured: Baseline
Measuring corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measured: 1 minute after every itch/pain induction for 10 minutes
Measuring corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measured: post induction (1 minute)
Measuring corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measured: post induction (30 minutes)
electromyography (EMG) recordings
For electromyography (EMG) recordings, two electrodes (Disposable Electrode Pack - AMBU Neuroline 720) will be placed on the muscle belly of the FDI muscle. The reference electrode will be placed on the ulnar styloid process of the left arm.
Measured: 1 minute after every itch/pain induction
Secondary outcomes (7)
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.
Measured: Baseline
Itch Catastrophizing Scale (ICS).
he 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.
Measured: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
The RST-PQ contains the following subscales: the Fight-Flight-Freeze System (FFFS, 10 items), which represents a defensive factor related to active avoidance of adverse stimuli; the Behavioral Inhibition System (BIS, 23 items), which represents a defensive factor related to anxiety and passive avoidance of adverse stimuli; and the Behavioral Approach System (BAS, 32 items), which reflects reward interest, goal-drive persistence, reward reactivity, and impulsivity. In total, 65 items have to be answered on a 4-point Likert-type scale
Measured: Baseline
The Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep
Measured: Baseline
Depression, Anxiety, Stress Scale (DASS-21)
he 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)
PANAS measures positive and negative affect dimensions. Twenty words are associated with the subject's current feelings and have to be rated on a 5-points Likert-type scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies 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
- Model description
- we apply one of three experimental methods in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%) Histamine is an itch-provoking substance formed in the human body. For 10 minutes after this, you are to assess the itch and pain you perceive on a scale from 0 to 10, in which 0 is no itch/pain and 10 is worst itch/pain imaginable. We will also apply non-invasive magnetic stimulations to your brain.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT06470737
- Sponsor's protocol ID
- N-20240004 1st subproject
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2024
- Last updated
- 22 Nov 2024
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Neurophysiological and Psychological Aspects of Itch
- ClinicalTrials.gov ID
- NCT06470737
- Acronym / sponsor ID
- N-20240004 1st subproject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 24 Jun 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 experiment consists of three experimental sessions conducted over a period of two weeks. In the first experimental session, we apply in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%). For 10 minutes after this, you are to assess the itch and pain you perceive. We will also apply non-invasive magnetic stimulations to your brain. During the experiment, you should fill in questionnaires. The second and third experimental sessions are conducted in the same way as the first session.
The purpose of this experiment is to investigate the changes appearing in the brain during artificially applied itch and pain corticomotor adaptations.
Detailed description
The experiment consists of three experimental sessions conducted over a period of two weeks. The duration of each session is approx. two hours. In the first experimental session, we apply one of three experimental methods in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%) Histamine is an itch-provoking substance formed in the human body. For 10 minutes after this, you are to assess the itch and pain you perceive on a scale from 0 to 10, in which 0 is no itch/pain and 10 is worst itch/pain imaginable. We will also apply non-invasive magnetic stimulations to your brain. This is done using a magnetic coil which is held over your head. During the experiment, you should fill in questionnaires about how you experience itch/pain and about your personality. The second and third experimental sessions are conducted in the same way as the first session. However, we will apply one of the other two experimental methods than the one used in the first session (i.e., first session: histamine, second session: plant needles, third session: injection with salt water). The experimental methods will be applied in random order.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- we apply one of three experimental methods in your hand: either an injection of salt water (7% NaCl) or we apply small needles from the plant mucuna pruriens or histamine (1%) Histamine is an itch-provoking substance formed in the human body. For 10 minutes after this, you are to assess the itch and pain you perceive on a scale from 0 to 10, in which 0 is no itch/pain and 10 is worst itch/pain imaginable. We will also apply non-invasive magnetic stimulations to your brain.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Hypertonic Saline, Other: Histamine, Other: Cowhage, Device: Transcranial magnetic stimulation (TMS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- 18-60 years
- Speak and understand English
Key exclusion criteria (13 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder (e.g., heart stroke), or psychiatric diagnoses (e.g. depression) that may affect the results
- Current use of medications that may affect the trial, such as antihistamines, antipsychotics, and painkillers, as well as systemic or topical steroids
- Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
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 |
|---|---|---|
| Hypertonic SalineA bolus injection of hypertonic saline (7% NaCl) will be administered to the FDI muscle using a 1 mL syringe with a disposable needle (27G), and the volume of the bolus will be 0.2 mL | Other | Healthy volunteers |
| HistamineA small drop of histamine dihydrochloride will be applied to a previously determined area on the volar forearm, followed by a prick through the drop | Other | Healthy volunteers |
| CowhageThis insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area. | Other | Healthy volunteers |
| Transcranial magnetic stimulation (TMS)Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil. | Device | Healthy volunteers |
Primary outcome
Numeric rating scales (NRS)
Time frame: 1 minute after every itch/pain induction
NRS are essentially VAS but have tick marks spaced every centimeter so as to create 11-point scale (from 0 to 10). Subject can use these tick marks as a guide when they mark their severity on the scale.
Measuring corticospinal excitability
Time frame: Baseline
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measuring corticospinal excitability
Time frame: 1 minute after every itch/pain induction for 10 minutes
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measuring corticospinal excitability
Time frame: post induction (1 minute)
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
Measuring corticospinal excitability
Time frame: post induction (30 minutes)
Transcranial magnetic stimulation (TMS) will be used to evoke motor-evoked potentials (MEPs) in the muscle of interest and cortical responses (TMS-evoked potentials - TEPs) in the motor cortex with a figure-eight-shaped cone coil.
electromyography (EMG) recordings
Time frame: 1 minute after every itch/pain induction
For electromyography (EMG) recordings, two electrodes (Disposable Electrode Pack - AMBU Neuroline 720) will be placed on the muscle belly of the FDI muscle. The reference electrode will be placed on the ulnar styloid process of the left arm.
7 secondary outcomes
Pain Catastrophizing Scale (PCS).
Time frame: Baseline
Itch Catastrophizing Scale (ICS).
Time frame: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time frame: Baseline
The Pittsburg Sleep Quality Index (PSQI)
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
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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 Hypertonic Saline, Histamine and Cowhage in people with Itch 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 3 inclusion and 13 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 22 Nov 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. 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?
Numeric rating scales (NRS) (time frame: 1 minute after every itch/pain induction). The study lists 6 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 22 Nov 2024.