Virtual Reality Walking for Traumatic Brain Injury

(fNIRS Trial)

Overseen By Candy Tefertiller, PT, DPT, PhD, NCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Disqualifiers: Chronic TBI, Weight over 298 pounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to study brain activity in individuals with long-term traumatic brain injuries (TBI). It employs a special device called functional near-infrared spectroscopy (fNIRS) to safely monitor brain signals while participants walk on a treadmill with virtual reality (VR) visuals. The researchers aim to determine if this setup is safe and effective for data collection. Suitable candidates have experienced moderate to severe TBI, completed inpatient rehab, and continue to have balance issues. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance future TBI treatments.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for use in individuals with chronic TBI?

Research has shown that the functional near-infrared spectroscopy (fNIRS) device is safe for people. In a previous study, all participants handled the procedure well, and 87.5% found it acceptable. FNIRS is non-invasive, meaning it doesn't require surgery or use radiation, making it a safe choice for checking brain activity. Researchers have used the device to study brain function in people with traumatic brain injuries (TBI) without any serious side effects. Overall, fNIRS appears to be a safe and effective tool for examining brain activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) walking with functional near-infrared spectroscopy (fNIRS) for traumatic brain injury (TBI) because it offers a unique, non-invasive way to study brain activity during movement. Unlike standard rehabilitation methods that might not provide real-time brain monitoring, this technique uses fNIRS to measure brain function while participants walk on a VR treadmill. This approach not only enhances the rehabilitation experience by providing engaging, interactive feedback but also allows scientists to gather valuable data on brain recovery in a real-world setting. The portable nature of the fNIRS device, which is lightweight and worn like a backpack, makes it easier to use in various clinical environments.

What evidence suggests that using fNIRS is effective for analyzing brain activity in individuals with chronic TBI during VR treadmill training?

Research has shown that functional near-infrared spectroscopy (fNIRS), a technology used in this trial, could aid in managing traumatic brain injury (TBI). Studies suggest that fNIRS detects changes in brain activity, even in patients with severe brain injuries who might not display obvious signs of awareness. This technology monitors brain oxygen levels and blood flow, crucial for assessing brain health after a TBI. Additionally, fNIRS can identify issues like bleeding inside the skull. Although more research is needed, these capabilities make fNIRS a promising tool for understanding and potentially improving brain function in TBI patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Candy Tefertiller, PT, DPT, PhD, NCS

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with chronic traumatic brain injury (TBI) who are able to participate in treadmill training. Specific eligibility criteria aren't provided, but typically participants must be medically stable and capable of giving informed consent.

Inclusion Criteria

Weight less than 298 pounds and able to fit appropriately in the treadmill system

Ability to follow directions/standardized instructions

I can walk ten feet with help from one person or with a device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a single session of treadmill training with and without VR while wearing the fNIRS device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Near-Infrared Spectroscopy (fNIRS)

Trial Overview The study is testing the use of a portable brain-scanning device called fNIRS during treadmill exercises that may or may not include virtual reality (VR). The goal is to see if fNIRS can effectively measure brain activity in people with TBI under these conditions.

How Is the Trial Designed?

Group I: Stepping on a Virtual Reality Treadmill with a Functional Near-infrared Spectroscopy (fNIRS) Device Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9352882/

Functional near-infrared spectroscopy as a potential ... In conclusion, based on fNIRS technology, the results of this study find that patients with neurocognitive disorders after TBI show decreased activation ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07106216

Study Details | NCT07106216 | Evaluating Near-infrared ... Data recorded from these devices will help determine if they can effectively monitor additional complications and outcomes in adults over 18 ...

3. mdpi.com mdpi.com/1424-8220/21/5/1586

Near-Infrared Spectroscopy (NIRS) in Traumatic Brain ... Overall, current evidence suggests that NIRS allows the detection of intracranial bleeding, the assessment of brain tissue oxygenation and cerebral perfusion.

4. pnas.org pnas.org/doi/10.1073/pnas.2402723121

Functional near-infrared spectroscopy: A novel tool for ... The results demonstrate that fNIRS can detect preserved awareness in patients with severe brain injury despite the absence of any observable behavioral ...

5. jmedcasereportsimages.org jmedcasereportsimages.org/articles/JCRMHS-1279.pdf

Tracking the Recovery of a Mild Traumatic Brain Injury ... The purpose of this case study was to provide a proof of concept for performing a combined functional near-infrared spectroscopy. (fNIRS) and 60 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40203004/

A Functional Near-Infrared Spectroscopy Feasibility Study Results: The fNIRS protocol used in this study was safe for all participants and acceptable to 87.5% of participants. FNIRS data acquisition and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505624000303

Human factor engineering of point-of-care near infrared ... NIRS devices for TBI screening offer several advantages over traditional imaging techniques. They are non-invasive, eliminating the need for ionizing radiation ...

8. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2019.00145/full

Mental Fatigue and Functional Near-Infrared Spectroscopy ... Pathological mental fatigue after mild traumatic brain injury (TBI-MF) is characterized by pronounced mental fatigue after cognitive activity.