NCT05253508

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

February 2, 2022

Last Update Submit

February 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Study Arms (1)

Healthy human participants

EXPERIMENTAL

ring-block anaesthesia with lidocaine in one of the two visits

Drug: Lidocaine 2% Injectable Solution

Interventions

A digital nerve block by injections to the base of the finger

Healthy human participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older;
  • No reported psychiatric or neurological disorders;
  • Able to provide informed consent;
  • Voluntary participation with written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reinier Haga Orthopedic Center

Zoetermeer, 2725 NA, Netherlands

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Repeated-measures design, order randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 23, 2022

Study Start

January 1, 2022

Primary Completion

March 15, 2022

Study Completion

March 30, 2022

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations