Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

NCT05956067 | Suspended FDA Device

• 1 other identifier: 23-1301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.

Conditions

Fibromyalgia; Chronic Low-back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Feasibility: Percent follow-up

  Percent follow-up for 1 week baseline visit. Follow-up greater than 70% will be considered feasible.

  1 week

• Feasibility: Percent of flash surveys completed

  Percent of flash surveys completed during light stimulation period. 0% is the lowest and 100% is the highest. Higher percentages indicate greater percent of flash surveys completed.

  1 week

• Feasibility: Self-reported light stimulation sessions completed

  Self-reported light stimulation sessions completed by flash survey administered after each light stimulation session over the 5 day stimulation period. Number of sessions will be reported the minimum is 0 and the maximum is 5.

  1 week

Secondary Outcomes (5)

• Change in pain intensity after stimulation

  Baseline, 1 week

• Change in pressure pain threshold

  Baseline, 1 week

• Change in Conditioned Pain modulation

  Baseline, 1 week

• Change in Temporal Summation

  Baseline, 1 week

• Change in activity measured with an accelerometer

  1 week prior to baseline and 1 week during light stimulation

Study Arms (3)

Equal energy white stimulus

EXPERIMENTAL

Equal energy white light at 500 lux. The International Commission on Illumination (CIE) coordinates of this light are (x=y=0.33), indicating that the stimulus appears uniformly white which means that the activation of each of the three classes of photoreceptors are equivalent, thus silencing any chromatic opponency. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

Device: Equal Energy White stimulation

Green light stimulus

EXPERIMENTAL

Green light at 500 lux. Participants will view 545 nm green light delivered via a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

Device: Green Light stimulation

S-cone modulating white light

EXPERIMENTAL

The S-cone modulating light stimulus will alternate between two light conditions at 500 lux that will activate the S-cones by about 100x differentially between the two conditions while maintaining the L- an M-cones at constant activation between the two alternating conditions using 427 nm versus 545 nm light. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.

Device: S-cone modulating white light

Interventions

Green Light stimulation DEVICE

A portable battery-operated ganzfeld light display will be used to deliver green light for 2 hours per day for 5 consecutive days.

Green light stimulus

Equal Energy White stimulation DEVICE

A portable battery-operated ganzfeld light display will be used to deliver white light for 2 hours per day for 5 consecutive days.

Equal energy white stimulus

S-cone modulating white light DEVICE

A portable battery-operated ganzfeld light display will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.

S-cone modulating white light

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults greater than or equal to 18 and less than or equal to 65.
• Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
• Individuals who experience an average pain severity greater than 4/10 in intensity at baseline.
• Willingness to wear a battery-operated portable ganzfeld light stimulator device for 2 hours per day at the same time each day (ideally complete the light therapy session between 5 am-10 am each morning) for 5 days.
• Alert and oriented, and able to provide informed consent
• Ability to read and speak English to complete validated questionnaires.

You may not qualify if:

• Vision disorders or conditions resulting in severe vision impairment or blindness
• Individuals with self-report of color blindness
• Prisoner Status
• Pregnancy
• No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger the patient).
• History of seizure disorder

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University Of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Matthew C Mauck, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 21, 2023
• Study Start: August 25, 2023
• Primary Completion: July 17, 2026
• Study Completion: July 29, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 1 year after completion of the study and will be available for an additional 2 years.
• Access Criteria: Data use agreement with University before deidentified information requested will be shared.

Locations

US (1)