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Traumatic Brain InjuryfNIRSNCT06276894

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

A study testing Motek C-Mill™ treadmill and training session with and without VR wearing the fNIRS cap in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Motek C-Mill™ treadmill and training session with and without VR wearing the fNIRS cap
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
27 May 2024to 1 Jun 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Craig Hospital

    Englewood, Colorado, 80113

Other trials in United States

About this study

Official title: Using Functional Near-Infrared Spectroscopy (fNIRS) to Assess Neural Activity During a Virtual Reality Walking Intervention: A Feasibility Study

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.

Read the detailed description

Each year, an estimated 2.9 million Americans sustain traumatic brain injuries (TBI) that result in emergency department visits, hospitalizations, and death. Although there are many treatment strategies in the early weeks and months after TBI, millions of individuals live with residual disability. This residual, chronic disability often includes significant impairments in functional abilities, like mobility, along with unresolved neurophysiological deficits. Because better mobility is directly linked to improved quality of life and enhanced societal participation, interventions designed to improve mobility in chronic TBI are essential.

One candidate intervention that could improve mobility in chronic TBI is virtual reality (VR). VR systems are computer-based applications that allow an individual to view and dynamically interact with a simulated environment in real-time. Evidence suggests that VR may enhance motor learning and ultimately neuroplasticity (the ability to reorganize synaptic connections in response to learning), as VR provides users with increased sensory stimulation, a more immersive environment, and real-time feedback. VR has been used to improve balance and mobility deficits associated with multiple neurologic conditions, including TBI. Neuroimaging studies have found that VR engagement can activate various cortical networks, including the visual cortex, parietal cortex, and premotor cortex, among others, which may impact motor outcomes. Craig has been evaluating the impact of VR use in TBI since 2012 when they conducted a site-specific study evaluating VR balance training in the home in comparison to a written home exercise program. Importantly, it was found that both interventions elicited significant improvements in clinical measures of balance in individuals with chronic TBI, but did not find between group differences.

In the current Traumatic Brain Injury Model Systems (TBIMS) grant, the investigator hypothesized that combining treadmill training (TT) and VR would increase cortical excitability which would concurrently enhance activation of the neuromuscular system. Subsequently, this intervention would improve walking, balance, and cognitive outcomes - as evaluated with gold standard clinical measures. However, more research is needed to test this hypothesis and address knowledge gaps, as efficacy for TT + VR has not been established, specific "responders" to TT + VR interventions have not been identified, and the plausible mechanisms associated with response have not been established. Specifically, studies have not yet evaluated the relationship between clinical outcomes and cortical activation.

To address these gaps, the investigators are proposing a translational research approach. Translational research integrates basic and clinical science to better understand disorders like chronic TBI and to create enhanced diagnostics and treatments to expedite recovery processes. Here, the investigators propose to pair a neuroscience method with clinical interventions in adults with chronic TBI. Specifically, they plan to use portable a neuroimaging device, functional near-infrared spectroscopy (fNIRS), to measure neural activity during a TT + VR intervention to support future research and clinical initiatives in VR.

fNIRS is a neuroimaging technique that uses near-infrared light to evaluate changes in brain activity via proxy measures of oxygenated (HbO) and deoxygenated hemoglobin (HbR). Specifically, following neural activity, oxygen is pulled from hemoglobin resulting in an immediate increase of HbR. Next, the oxygen reduction elicits an increase in localized cerebral blood flow (CBF) - a mechanism called neurovascular coupling. As CBF increases, a greater concentration of HbO can be detected. Both HbR and HbO have optical properties, meaning that their concentrations can be measured with near-infrared light. Thus, fNIRS can detect localized neural activity by evaluating HbR and HbO, and increases in HbO concentrations reflect site-specific increases in neural activity.

In summary, this proposed pilot study is designed to assess the feasibility of using portable fNIRS to measure neural activity during a TT + VR intervention in adults with TBI. Establishing feasibility will allow us to use fNIRS in future studies comparing different intervention types. These outcomes will advance VR research and enhance the scientific understanding of clinical and physiological outcomes following VR interventions, ultimately informing clinical care.

Being tested
Motek C-Mill™ treadmill, training session with and without VR wearing the fNIRS cap
Keywords
fNIRS, Virtual Reality, Treadmill Training, Neuroimaging
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motek C-Mill™ treadmillDevice

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

  • training session with and without VR wearing the fNIRS capOther

    training session with and without VR wearing the fNIRS cap

Study groups in NCT06276894
Study groupRoleWhat they receive
Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) DeviceOtherThis 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.
Receives: Device: Motek C-Mill™ treadmill; Other: training session with and without VR wearing the fNIRS cap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start27 May 2024
  3. Primary completion28 May 2024
  4. Study completion1 Jun 2025

Resources

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
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06276894
Sponsor's protocol ID
IRB #2064530-1
Acronym
fNIRS
Status last verified
Mar 2026
First submitted
18 Jan 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motek C-Mill™ treadmill and training session with and without VR wearing the fNIRS cap in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.

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 8 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 2026. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability) (time frame: 1 day). The study lists 3 primary outcomes in all. 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 30 Mar 2026.

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