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Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer
Real-Time Evaluation of Severity of Perceived Pain in Patients With Cancer by Using Functional Near-Infrared Spectroscopy (fNIRS), and Investigation of Pain Relief Utilizing Virtual Reality Technologies
2 other identifiers
interventional
106
1 country
1
Brief Summary
This study aims to develop objective tools for assessing perceived pain severity in cancer patients and survivors, evaluate the sustained effectiveness of non-pharmacological interventions such as virtual reality in reducing pain and medication use, and create tools for the early detection of neuropathy. Wireless, non-invasive neuroimaging methods, including functional near-infrared spectroscopy (fNIRS), will be used to support these objectives
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
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
July 12, 2022
CompletedFirst Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2026
CompletedApril 29, 2026
April 1, 2026
3.7 years
May 30, 2024
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Gain knowledge of Brain activity during pain
Computational neuroscience algorithms and graph theories will be used to extract informative patterns of brain activity and diagnose the stimulated brain areas associated with pain and pain severity as well as any relationships between pain severity, functional near-infrared spectroscopy (fNIRS) measures, and visual perception.
Up to 16 months
Secondary Outcomes (2)
Determine if utilizing virtual reality technologies significantly alleviate pain through distraction
Up to 16 months
Reason for pain alleviation caused by virtual reality techniques
Up to 16 months
Study Arms (6)
Group A (fNIRS)
EXPERIMENTALParticipants undergo fNIRS for 10 minutes.
Group B (fNIRS, VR)
EXPERIMENTALPatients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.
Group C (fNIRS)
EXPERIMENTALPatients undergo fNIRS for 10 minutes.
Group D Arm 1 - VR
EXPERIMENTALPatients undergo Therapeutic VR program for up to 30 minutes four times per week
Group D Arm II - Sham VR
EXPERIMENTALPatients undergo placebo VR program for up to 30 minutes four times per week.
Group E
EXPERIMENTALCold stimulation on day 1 of each chemotherapy cycle and day 3.
Interventions
Undergo fNIRS
Undergo relaxation period using VR
Eligibility Criteria
You may qualify if:
- Cancer pts as well as healthy volunteers) must be over the age of 18
- Participants in Groups A or C (cancer pts as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes
- Participants in Group B and C: Patient can be in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing acute pain from treatment or cancer itself. Cancers include but are not limited to: breast, thoracic, lung, kidney, colon, pancreatic, etc.
- Participants in Group B and C must be free from other forms of chronic pain, e.g., rheumatologic pain, must be free from neurologic illnesses, e.g., stroke, and must have no brain metastases which could interfere with brain functions
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Men and women of 40-80 yrs old
- Stage I-III lung cancer survivors who have undergone lung resection and developed persistent post-thoracotomy pain (PPTP)
- Willing to comply with study procedures
- Be able to remain sedentary for 20 minutes during functional near-infrared spectroscopy (fNIRS) data recording sessions, including 10 minutes each for fNIRS system setup and 10 minutes data recording.
- Female participants must not be pregnant to participate in this study. During the third trimester, the fetus's brain is significantly developed and may interact with the mother's brain. As this study involves recording brain activity using fNIRS, it is necessary to exclude pregnant individuals to ensure the quality of the research data.
- Be able to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs.
- Must be free from other forms of chronic pain, e.g., rheumatologic pain
- Must be free from neurologic illnesses, e.g., stroke
- Had no brain metastases which could interfere with brain functions
- Must understand the investigational nature of the study and sign a written informed consent form approved by the Independent Ethics Committee/Institutional Review Board.
- +5 more criteria
You may not qualify if:
- Unwilling or unable to follow protocol requirements
- Currently pregnant or planning to become pregnant during the study period
- FOR GROUP B :
- Medical condition predisposing to nausea or dizziness.
- Hypersensitivity to flashing light or motion.
- stereoscopic vision or severe hearing impairment.
- Unwillingness or inability to follow protocol requirements.
- Individuals with impaired decision-making capacity.
- Individuals with electronic or metallic implants in the head.
- Unable to remove any items from their scalp that might block direct contact between the fNIRS optodes and the skin. This includes, but is not limited to, wigs and hijabs
- Prisoners
- individuals with hypersensitivity to flashing lights or motion. Rationale: Such hypersensitivities can increase the risk of seizures or severe discomfort when exposed to common elements of VR programs, which frequently include rapid visual and motion stimuli.
- individuals with impaired stereoscopic vision or severe hearing impairments. Rationale: VR programs often involve moving objects, flashing lights, and immersive soundscapes. Participants must have sufficient vision and hearing to effectively engage with and safely navigate these environments.
- Currently pregnant or planning to become pregnant during the study period.
- Unwillingness or inability to follow protocol requirements.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somayeh B Shafiei
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 13, 2024
Study Start
July 12, 2022
Primary Completion
April 10, 2026
Study Completion
April 10, 2026
Last Updated
April 29, 2026
Record last verified: 2026-04