Aalborg University
Gistrup, 9260, Denmark
NCT Number: NCT06470737
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Gistrup, 9260, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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) 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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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".
Time frame: Baseline
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).
Time frame: Baseline
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.
Aalborg University
Other
Investigation of the Neurophysiological and Psychological Aspects of Itch
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04387851
Itch, Neurologic Manifestations
Leiden, South Holland, Netherlands
View Trial DetailsNCT07122973
Itch, Neurologic Manifestations
Gistrup, Aalborg, Denmark
View Trial DetailsNCT06245564
Itch, Pathological Conditions, Signs and Symptoms
Gistrup, Aalborg, Denmark
View Trial DetailsNCT03928093
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Toronto, Ontario, Canada
View Trial Details