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
Overview
- Phase
- Not Applicable
- Intervention
- Questionnaire Administration
- Conditions
- Not specified
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Gain knowledge of Brain activity during pain
- Status
- Terminated
- Last Updated
- 3 days ago
Overview
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
Detailed Description
PRIMARY OBJECTIVES: I. Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation. II. Find the relationship between fNIRS (functional near-infrared spectroscopy) features and severity of pain as well as the relationship (if any) between perceived pain severity and psychological factors. III. Understand the acute cold dysesthesias with oxaliplatin and how this correlated with more chronic neuropathy IV. Investigate the sustained effects of therapeutic virtual reality versus Sham virtual reality on pain severity and medication doses. V. Monitor VR-induced changes of brain activity to find out the underlying mechanisms of pain alleviation. SECONDARY OBJECTIVES: I. Investigate the effect of demographic factors on perceived pain severity and VR-inducated pain alleviation \- Investigate the effects of repeated VR use on doses of medications. OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B, C , D or E. GROUP A: Participants undergo fNIRS for 10 minutes. GROUP B: Patients undergo fNIRS for 10 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes. GROUP C: Patients undergo fNIRS for 10 minutes. GROUP D: Patients are randomized to 1 of 2 arm: ARM I - Patients use VR for up to 30 minutes. ARM II: Patients use Sham VR Program for up to 30 minutes GROUP E: Cold pack stimulation on Day 1 of each chemotherapy cycle and day 3.
Investigators
Eligibility Criteria
Inclusion Criteria
- •GROUPS A, B and C:
- •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
- •Inclusion Criteria - GROUP D:
- •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
Exclusion Criteria
- •GROUPS A, B and C:
- •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.
Arms & Interventions
Group C (fNIRS)
Patients undergo fNIRS for 10 minutes.
Intervention: Questionnaire Administration
Group D Arm II - Sham VR
Patients undergo placebo VR program for up to 30 minutes four times per week.
Intervention: Virtual Technology Intervention
Group A (fNIRS)
Participants undergo fNIRS for 10 minutes.
Intervention: Functional Near-Infrared Spectroscopy
Group A (fNIRS)
Participants undergo fNIRS for 10 minutes.
Intervention: Questionnaire Administration
Group B (fNIRS, VR)
Patients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.
Intervention: Functional Near-Infrared Spectroscopy
Group B (fNIRS, VR)
Patients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.
Intervention: Questionnaire Administration
Group B (fNIRS, VR)
Patients undergo fNIRS for 10 minutes followed by a relaxation period using VR for over 15 minutes.
Intervention: Virtual Technology Intervention
Group C (fNIRS)
Patients undergo fNIRS for 10 minutes.
Intervention: Functional Near-Infrared Spectroscopy
Group D Arm 1 - VR
Patients undergo Therapeutic VR program for up to 30 minutes four times per week
Intervention: Virtual Technology Intervention
Group E
Cold stimulation on day 1 of each chemotherapy cycle and day 3.
Intervention: Cold Stimulation
Outcomes
Primary Outcomes
Gain knowledge of Brain activity during pain
Time Frame: Up to 16 months
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.
Secondary Outcomes
- 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)