Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention

NCT06276894 | Completed

• 1 other identifier: IRB #2064530-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR.

Conditions

Traumatic Brain Injury

Keywords

fNIRS; Virtual Reality; Treadmill Training; Neuroimaging

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability)

  Monitoring and documenting adverse events such as falls or near-falls during TT + VR sessions

  1 day

• Acceptability of the intervention

  Monitored using the feasibility questionnaire (Translated English Version from Swedish) that assesses participants' experience during or after the gait test. There are 9 questions that are rated on a 4-point Likert scale from strongly disagree to strongly agree with an "I don't know" option.

  1 day

• fNIRS Data Quality

  Assessed using the quantitative markers in the signal optimization process. Data will be acquired from participants when we reach acceptable or excellent values at each channel and signal quality values over 7.4%. Following data acquisition, fNIRS data will be uploaded into Satori analysis software (nirx.net). Study investigators will use visual inspection to evaluate raw data and then confirm that all data analysis steps - optical density conversion, spatial registration, and temporal processing - have been completed successfully. Given that this is movement-based paradigm, research investigators will carefully examine the presence of motion artifacts (e.g., noise created from head movements) in raw data and confirm that these have been detected and removed from analyzed data.

  1 day

Study Arms (1)

Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) Device

OTHER

This is a single-arm safety and feasibility study that will enroll up to 15 participants. Those meeting inclusion/exclusion criteria will be invited to enroll in the study. Following a thorough informed consent process, each participant will participate in one session of data acquisition. fNIRS data will be acquired with the NIRSport2, which is a fully-portable system as the device (weighs less than 2 pounds) is secured to the participant's back with backpack-like straps. Following signal optimization and signal quality checks, baseline fNIRS data will be obtained during 60-second periods of quiet, static standing. Then, each participant will complete up to 24 minutes of stepping on a treadmill with and without VR wearing the fNIRS cap. This training will be carried out in two 12-minute sessions with individuals being offered a sitting rest break in between. Training will be completed using the Motek C-Mill™ treadmill, which provides optional body weight support and VR feedback.

Device: Motek C-Mill™ treadmill; Other: training session with and without VR wearing the fNIRS cap

Interventions

Motek C-Mill™ treadmill DEVICE

We will enroll 10 to 15 participants to participate in a VR treadmill training session while wearing an fNIRS cap.

Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) Device

training session with and without VR wearing the fNIRS cap OTHER

training session with and without VR wearing the fNIRS cap

Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe TBI that required inpatient rehabilitation program;
• at least one-year post-injury at time of consent;
• weight less than 298 pounds and able to fit appropriately in the treadmill system;
• intact skin (no open lesions/bandages) in the area of treadmill harness contact;
• able to walk ten feet requiring the assistance of no more than one person (bracing and assistive devices allowed);
• self-reports ongoing balance deficits;
• ability to follow directions/standardized instructions;
• minimum 18 years of age at consent

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Candy Tefertiller, PT, DPT, PhD, NCS

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 26, 2024
• Study Start: May 27, 2024
• Primary Completion: May 28, 2024
• Study Completion: June 1, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)