Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05836038
Other study ID # HM&E123
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information

Verified date May 2024
Source Tufts University
Contact Nancy Baker, ScD
Phone 617 627-5562
Email nancy.baker@tufts.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators will evaluate the feasibility of "puppeting" a virtual hand with the opposite hand in increasing complex movements and the effect of visio-tactile stimuli on embodiment to determine if it is a necessary part of the process.


Description:

Embodiment refers to a subjective experience where a person views a simulated body and its properties are experienced as if they were the person's own biological body (1). Embodiment is notably seen in the rubber hand illusion (2): a rubber hand is made to substitute for the real hand using visio-tactile stimulation to connect the rubber hand to the participant. In visio-tactile stimulation, the real hand is hidden from view and the rubber hand is positioned where the real hand should be. Both hands are simultaneously stroked while the participant views the rubber hand. Within a short time, the rubber hand "feels" touch and pain, independent of the real hand. In this study investigators will evaluate the ability to enable embodiment in a virtual reality environment. After providing background information, participants will then complete the "Real Hand Session" of the Study Protocol (See below) using their real hand to move the same side virtual hand (e.g. left real hand movements will move left virtual hand). Participants will complete Usability and Embodiment /Presence surveys After the Actual Protocol, participants in the VTS group will receive visio-tactile stimuli. They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern. Participants in the NoVTS will spend the same amount of time looking at their virtual hand without the touching (~1 minute). For the "Puppet Session" participants will complete the same tasks as the "Real Hand Session"(See Below) but movement of the real hand will "puppet" the opposite virtual hand (right real hand movements will move left virtual hand). After completing the session participants will complete Usability and Embodiment /Presence surveys Study Protocol Sessions.(20 to 30 minutes). All take place in the virtual environment Hand Movement- Press a 36-button sequence 4x Bilateral Task - "Catch" 36 "fireflies" with both hands 4x. Unilateral Task - "Catch 36 "fireflies" with one hand 4x. Avoidance Task - Press a 36-button sequence. A "dangerous" virtual obstacle (e.g., sawblade) will be placed in the path of the virtual hand during some of the trajectories. Investigators will see how far from the most efficient trajectory participants moves to avoid the object Hypotheses H1: Participants will demonstrate a greater sense of embodiment with visio-tactile stimuli (VTS) than without visio-tactile stimuli (NoVTS) H1a: Participants in the VTS group will report higher levels of embodiment than those in the NoVTS group. H1b: Participants will demonstrate significantly better motor performance in the VTS group than the NoVTS group. H1c: Participants in the VTS group will demonstrate greater avoidance of "dangerous items" than those in the NoVTS group H1d: Participants in the VTS group will report better usability of the embodied virtual hand than those in the NoVTS group. H2: Motor Performance of the "Puppeted" virtual hand will be similar to the "Actual" virtual hand.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • 30 adult participants (18+) - Right Handed Exclusion Criteria: - Seizure, loss of awareness, or other symptom linked to an epileptic condition in the last 5 years - Blind; - Unable to use hands to reach and grasp items - Implanted medical device such as a pacemaker, defibrillator, or hearing aid. - Contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face or head that would come in contact with the headset; - Unable to understand and respond to English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Visio-Tactile Stimulation
They will see their virtual hand touched while simultaneously feel their opposite real hand touched in the same pattern.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Outcome

Type Measure Description Time frame Safety issue
Primary Motor Performance - Speed We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate speed Through study completion, 1 day
Primary Motor Performance - Velocity We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate velocity Through study completion, 1 day
Primary Motor Performance - Precision We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate Precision Through study completion, 1 day
Primary Motor Performance - Trajectory We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate trajectory Through study completion, 1 day
Primary Motor Performance - Path Length We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate path length Through study completion, 1 day
Primary Motor Performance - Time to Target We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate Time to target Through study completion, 1 day
Primary Motor Performance - Error rate We will track and store participant movements during each task via the VR headset. These movements will be downloaded and processed to calculate error rate Through study completion, 1 day
Primary Embodiment Participants perception of immersion during VR experience: Using Peck's Embodiment Scale (16 items scored on a 7 point likert scale with a final score between 1 and 7 with a higher score indicating greater emobidment) and the IPQ Presence questionnaire (14 items on a 7 point likert scale with a higher score indicating greater embodiment) Through study completion, 1 day
Primary Presence Participants perception of immersion during VR experience: IPQ Presence questionnaire (14 items on a 7 point likert scale with a score between 7 and 98 and a higher score indicating greater presence) Through study completion, 1 day
Primary Usability - Engagement Participants perception of the ease of use of the VR system using the User Engagement Scale (a 12 item 1-5 pt likert scale with scores between 12 and 60 and a higher score indicating greater usability) Through study completion, 1 day
Primary Usability - Task Demands Participants perception of the ease of use of the VR system using the NASA Task Index (6-item scored on 10 point VAS. Items are weighted by subject perception of what is important part of task. Higher score indicates greater task demand) Through study completion, 1 day
Primary Usability - ease of use Participants perception of the ease of use of the VR system using the System Usability Scale (10 item scored on 1-5 likert, scores are converted to a 100 scale with a higher score indicating greater ease of use) Through study completion, 1 day
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1