Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

NCT ID: NCT05956067

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2026-07-29

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low-back Pain Chronic Pain Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Equal energy white stimulus

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.

Group Type EXPERIMENTAL

Equal Energy White stimulation

Intervention Type DEVICE

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

Green light stimulus

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.

Group Type EXPERIMENTAL

Green Light stimulation

Intervention Type DEVICE

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

S-cone modulating white light

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.

Group Type EXPERIMENTAL

S-cone modulating white light

Intervention Type 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.

Interventions

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Green Light stimulation

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

Intervention Type DEVICE

Equal Energy White stimulation

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

Intervention Type DEVICE

S-cone modulating white light

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew C Mauck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University Of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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23-1301

Identifier Type: -

Identifier Source: org_study_id

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