Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456411
• Other study ID #: I 1720121
• Secondary ID: NCI-2021-11854I
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: July 12, 2026

Study information

• Verified date: June 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical trial attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.

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 visual perception.

SECONDARY OBJECTIVES:

I. Investigate the effect (and the reasoning of the effect) of alleviating severity of perceived pain utilizing virtual reality techniques.

II. Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques and/or cognitive distraction.

OUTLINE: Healthy participants are assigned to group A. Cancer patients are randomized to group B or group C.

GROUP A: Participants undergo fNIRS for over 15 minutes.

GROUP B: Patients undergo fNIRS for over 15 minutes followed by a relaxation period using virtual reality (VR) for over 15 minutes.

GROUP C: Patients undergo fNIRS for over 15 minutes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 12, 2026
• Est. primary completion date: July 12, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study participants (cancer patients as well as healthy volunteers) must be over the age of 18

• Study participants (cancer patients as well as healthy volunteers) need to be able to be in a sedentary posture for approximately 20 minutes

• For cancer participants: in any stage of cancer treatment, such as diagnosis, treatment (surgery, chemotherapy, immunotherapy, radiation), recovery, remission and is experiencing acute pain from treatment. Cancers include but are not limited to: breast, thoracic, kidney, etc.

• 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

Exclusion Criteria:

• Unwilling or unable to follow protocol requirements

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Renal Cell
• Kidney Carcinoma
• Kidney Neoplasms
• Malignant Solid Neoplasm
• Malignant Thoracic Neoplasm
• Neoplasms
• Thoracic Neoplasms

Intervention

Procedure:
• Functional Near-Infrared Spectroscopy
Undergo fNIRS

Other:
• Questionnaire Administration
Ancillary studies
• Virtual Technology Intervention
Undergo relaxation period using VR

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 4 years
Secondary	Determine if utilizing virtual reality technologies significantly alleviate pain through distraction	By utilizing virtual reality relaxation program we will analyze brain activity to find out how this distraction is controlled by the brain.	Up to 4 years
Secondary	Reason for pain alleviation caused by virtual reality techniques	Measured by fNIRS and quantified by signal processing and network neuroscience algorithms, to find out the reason for pain alleviation caused by virtual reality techniques. We will also investigate if cognitive distraction can be the main reason.	Up to 4 years