Sensory ProcessingNCT05253508
Propagation Waves in Tactile Material Perception
A study testing Lidocaine 2% Injectable Solution in people with Sensory Processing and Perception, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial summary
During the exploration of surfaces with the bare finger, vibratory signals arise and propagate through the finger and hand. While research into mechanical and neural response characteristics has demonstrated that these signals carry rich information about touched objects and their properties, only little is known… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Processing, Perception, Sense of Touch
- What is being tested?
- Lidocaine 2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2022to 30 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older;
- No reported psychiatric or neurological disorders;
- Able to provide informed consent;
- Voluntary participation with written informed consent.
Who cannot join
- Is pregnant or currently breastfeeding;
- Has a known Lidocaine allergy;
- Is currently undergoing any other medical intervention or taking part in a study involving one;
- Has a history of finger/hand/upper limb trauma or disease;
- Has a disease affecting normal motor functioning.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier Haga Orthopedic Center
Zoetermeer, 2725 NA
Nina Mathijssen, +31647208490, N.Mathijssen@rhoc.nl
About this study
Official title: An Investigation of the Contribution of Proximal Vibratory Cues in Tactile Material Perception'
During the exploration of surfaces with the bare finger, vibratory signals arise and propagate through the finger and hand. While research into mechanical and neural response characteristics has demonstrated that these signals carry rich information about touched objects and their properties, only little is known about the role these propagation waves play in human perception and to which extent the somatosensory system is able to collect information from afferents at more proximal locations than the skin-object surface. Using ring-block anaesthesia (lidocaine) we will temporarily inhibit haptic feedback sensations of healthy participants' index finger during interactions with 3D-printed surface probes that are systematically varied in two important material dimensions, namely their roughness and hardness (elasticity), while the participants carry out a well-established psychophysical discrimination task. The results will then be compared to a control condition without anaesthesia. An accelerometer sensor, placed on the dorsal side of the hand, will serve to simultaneously record the propagating tactile waves. Given their role in material perception, thermal cues will be monitored during the experiment with a thermometer and the hydration level of the fingertip skin will be measured regularly using a corneometer. This research will allow us to understand the role of propagation waves in material perception. It seeks to uncover some of the perceptual mechanisms that remain intact during surface discrimination of textured, compliant surfaces, while local information is temporarily inhibited. The results will have implications for how we provide feedback about material properties for sensorimotor control to this living with prosthetic limbs. It is hypothesised that propagation waves that arise during these haptic interactions contain behaviourally relevant information used for the discrimination of surface properties.
- Conditions
- Sensory Processing, Perception, Sense of Touch, Taction
- Being tested
- Lidocaine 2% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
A digital nerve block by injections to the base of the finger
| Study group | Role | What they receive |
|---|---|---|
| Healthy human participants | Experimental | ring-block anaesthesia with lidocaine in one of the two visits Receives: Drug: Lidocaine 2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in discrimination thresholds
The (statistical) difference between psychophysical measures (i.e., difference limen/discrimination thresholds) when the index finger is anaesthetised as compared to non-anaesthetized.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2022
- Primary completion15 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory ProcessingStudies 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
- Sequential
- Model description
- Repeated-measures design, order randomized
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Delft University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253508
- Sponsor's protocol ID
- NL75084.058.21
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Contribution of Proximal Vibratory Cues in Tactile Material Perception'
- ClinicalTrials.gov ID
- NCT05253508
- Acronym / sponsor ID
- NL75084.058.21
- Conditions
- Sensory Processing, Perception, Sense of Touch, Taction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Collaborators
- Delft University of Technology
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 23 Feb 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.
During the exploration of surfaces with the bare finger, vibratory signals arise and propagate through the finger and hand. While research into mechanical and neural response characteristics has demonstrated that these signals carry rich information about touched objects and their properties, only little is known about the role these propagation waves play in human perception and to which extent the somatosensory system is able to collect information from afferents at more proximal locations than the skin-object surface. Using ring-block anaesthesia (lidocaine) we will temporarily inhibit haptic feedback sensations of healthy participants' index finger during interactions with 3D-printed surface probes that are systematically varied in two important material dimensions, namely their roughness and hardness (elasticity), while the participants carry out a well-established psychophysical discrimination task. The results will then be compared to a control condition without anaesthesia. An accelerometer sensor, placed on the dorsal side of the hand, will serve to simultaneously record the propagating tactile waves. Given their role in material perception, thermal cues will be monitored during the experiment with a thermometer and the hydration level of the fingertip skin will be measured regularly using a corneometer. This research will allow us to understand the role of propagation waves in material perception. It seeks to uncover some of the perceptual mechanisms that remain intact during surface discrimination of textured, compliant surfaces, while local information is temporarily inhibited. The results will have implications for how we provide feedback about material properties for sensorimotor control to this living with prosthetic limbs. It is hypothesised that propagation waves that arise during these haptic interactions contain behaviourally relevant information used for the discrimination of surface properties.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated-measures design, order randomized
| Arm | Type | Receives |
|---|---|---|
| Healthy human participants | Experimental | Drug: Lidocaine 2% Injectable Solutionring-block anaesthesia with lidocaine in one of the two visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older;
- No reported psychiatric or neurological disorders;
- Able to provide informed consent;
- Voluntary participation with written informed consent.
Key exclusion criteria (5 listed)
- Is pregnant or currently breastfeeding;
- Has a known Lidocaine allergy;
- Is currently undergoing any other medical intervention or taking part in a study involving one;
- Has a history of finger/hand/upper limb trauma or disease;
- Has a disease affecting normal motor functioning.
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 |
|---|---|---|
| Lidocaine 2% Injectable SolutionA digital nerve block by injections to the base of the finger | Drug | Healthy human participants |
Primary outcome
Change in discrimination thresholds
Time frame: one year
The (statistical) difference between psychophysical measures (i.e., difference limen/discrimination thresholds) when the index finger is anaesthetised as compared to non-anaesthetized.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Sensory Processing
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
RecruitingObservational study
Perception, Sensation, Cognition and Action in Humans
Normal Physiology
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% Injectable Solution in people with Sensory Processing and Perception, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Driller (+45 30484333, k.k.driller@tudelft.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in discrimination thresholds (time frame: one year). 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 23 Feb 2022.