Light Therapy for Multiple Sclerosis

(NO-FATIGUE Trial)

Overseen By Peter Sguigna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Disease modifying therapy

Must not be taking: Melatonin analogues

Disqualifiers: Pregnancy, Alcohol abuse, MS relapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2.5 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of light therapy for individuals with progressive multiple sclerosis (MS), specifically targeting fatigue, a common and challenging symptom. The main aim is to assess the safety of the light therapy and gather information on its potential to reduce fatigue. Individuals diagnosed with primary progressive MS (PPMS) or secondary progressive MS (SPMS) who experience fatigue may be suitable candidates. Participants must have been on a stable MS treatment for at least three months before joining. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

You must be on a stable dose of your current medications for mood and fatigue for at least three months before the trial and keep them stable during the study. If you are taking melatonin analogues, you need to stop them for a specific period before the trial.

What prior data suggests that this light therapy is safe for patients with multiple sclerosis?

Research shows that light therapy is usually easy to handle and affordable. Studies have found that bright light therapy, a similar approach, is safe to use. In this trial, the researchers are exploring light therapy to help with fatigue in people with progressive multiple sclerosis. This study is in the early stages and aims to understand the safety of this new type of light therapy for participants. Although specific safety data for this exact treatment is limited, previous research suggests that light therapy is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for multiple sclerosis (MS), which often involve medications like disease-modifying therapies to slow progression, light therapy offers a non-invasive alternative focused on reducing fatigue. This therapy leverages circadian-focused light exposure to potentially improve energy levels and overall quality of life for those with progressive forms of MS, such as Primary Progressive MS (PPMS) and Secondary Progressive MS (SPMS). Researchers are excited about its unique approach, as it targets the body's natural rhythms rather than the immune system, which could lead to fewer side effects and a new way to manage MS-related fatigue.

What evidence suggests that light therapy might be an effective treatment for fatigue in multiple sclerosis?

Research has shown that light therapy might reduce tiredness in people with multiple sclerosis (MS). Exposure to bright light can reset the body's internal clock, which often becomes misaligned in individuals with MS. This reset might alleviate tiredness, a common and challenging symptom of MS. Some studies suggest that light therapy could also enhance overall well-being by reducing fatigue. Although more research is needed, early results offer hope for those experiencing MS-related tiredness. Participants in this trial will receive Circadian Focused Light Therapy to evaluate its potential in reducing fatigue in progressive MS. ^{6 7 8 9 10}

Who Is on the Research Team?

Peter Sguigna, MD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

This trial is for adults over 18 with progressive multiple sclerosis (either primary or secondary), as diagnosed by specific medical criteria. Participants must be stable on an FDA-approved MS treatment for at least three months and able to complete study procedures.

Inclusion Criteria

I have been diagnosed with primary or secondary progressive MS.

In the opinion of the investigator, able to complete study procedures

I have been on a stable dose of approved medication for my condition for at least 3 months.

Exclusion Criteria

Travel across two time zones within 3 months of study screening

I haven't taken melatonin analogues recently or have waited long enough after stopping.

I have had optic neuritis in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

At home sleep monitor, saliva collection, and completion of surveys

Treatment

Participants complete a light therapy program with daily visits for 3 days, followed by visits every 2-3 weeks for three additional visits

2.5 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Light Therapy

Trial Overview The trial is testing a new form of light therapy to see if it's safe for patients with progressive multiple sclerosis and if it can help reduce fatigue, a common symptom without direct FDA-approved treatments.

How Is the Trial Designed?

Group I: Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE) Experimental Treatment 1 Intervention

This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

International Progressive Multiple Sclerosis Alliance

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

There is a lack of sufficient evaluative studies on symptomatic treatment and rehabilitation for multiple sclerosis, leading to a poor evidence base for effective management strategies.

Recent advancements in understanding health outcomes and the mechanisms of disability in multiple sclerosis highlight the need for improved care models that offer comprehensive and accessible services to patients throughout their disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in neurorehabilitation in multiple sclerosis. Thompson, AJ.[2019]

Circadian rhythms, which are natural 24-hour cycles, play a crucial role in the immune system and can affect the onset and progression of diseases, particularly in the nervous and immune systems.

Chronotherapy, or timing the administration of immunomodulatory drugs to align with circadian rhythms, may enhance treatment effectiveness and minimize side effects for patients with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronobiological regulation of psychosocial and physiological outcomes in multiple sclerosis. De Somma, E., Jain, RW., Poon, KWC., et al.[2019]

This study investigates the effectiveness of bright white light therapy in reducing fatigue among multiple sclerosis (MS) patients, who often find fatigue to be their most disabling symptom.

Participants will be randomized to receive either bright light (10,000 lux) or dim red light for 1 hour twice daily over a 4-week treatment period, with the primary outcome being the change in fatigue severity measured by the Fatigue Severity Scale (FSS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial. Mateen, FJ., Manalo, NC., Grundy, SJ., et al.[2021]

Bright light therapy is effective for treating seasonal affective disorder and may also benefit various circadian rhythm sleep disorders, such as delayed and advanced sleep phase syndromes, based on a review of existing literature.

This therapy is relatively safe and its success relies on timing, suggesting that personalized approaches to treatment could enhance its effectiveness in managing sleep-wake rhythm misalignments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. Poirrier, R.[2006]

The current method of measuring disability in multiple sclerosis often focuses too much on walking ability, which may not accurately reflect the patient's experience or the effectiveness of treatments.

The proposed extended Q-TWiST method offers a new way to evaluate treatments by considering the quality of life and symptom management from the patient's perspective, potentially leading to better treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring patient-centered outcomes in neurologic disease. Extending the Q-TWiST method. Schwartz, CE., Cole, BF., Gelber, RD.[2019]

The Multiple Sclerosis Impact Scale-29 (MSIS-29) may not effectively capture the physical and psychological impacts of multiple sclerosis in patients with minimal disability, as shown in a study of 1882 patients from Phase 3 clinical trials.

Nearly half of the patients with low disability (EDSS score ≤ 2.5) reported fewer impacts than the MSIS-29 items typically account for, indicating that this scale may not be suitable for assessing treatment effects in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Multiple Sclerosis Impact Scale-29 (MSIS-29) have the range to capture the experience of fully ambulatory multiple sclerosis patients? Learnings from the ASCLEPIOS studies. Regnault, A., Loubert, A., Brennan, R., et al.[2023]

Inpatient rehabilitation for multiple sclerosis (MS) can improve functional independence but has limited long-term success in reducing neurological impairment, with severely disabled individuals benefiting as much as or more than those with less disability.

Exercise, particularly aerobic activities that include balance training and social interaction, has been shown to enhance fitness and maintain function in individuals with mild to moderate MS, suggesting that rehabilitation should be an ongoing process tailored to individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and rehabilitation for individuals with multiple sclerosis. Brown, TR., Kraft, GH.[2022]

Rehabilitation is currently the only effective treatment for multiple sclerosis (MS), focusing on restoring function and adapting daily life to manage disabilities.

While no medical treatment can consistently alter the disease's course, effective symptomatic therapies have improved the quality of life and increased life expectancy for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation in multiple sclerosis]. Kesselring, J., Mertin, J.[2006]

In a randomized sham-controlled trial involving 26 participants with multiple sclerosis, bright light therapy was evaluated for its effectiveness in reducing fatigue, but did not show a statistically significant difference compared to a dim red light sham intervention.

Despite the lack of significant results, participants generally experienced clinically relevant improvements in fatigue severity scores over the study period, suggesting that bright light therapy may still have potential benefits for managing MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy as a non-pharmacological treatment option for multiple sclerosis-related fatigue: A randomized sham-controlled trial. Voggenberger, L., Böck, M., Moser, D., et al.[2022]

Bright white light therapy (BWLT) is safe and well-tolerated in individuals with multiple sclerosis (MS)-associated fatigue, with no serious adverse events leading to discontinuation during the 10-week study involving 41 participants.

Both BWLT and dim red light therapy (DRLT) resulted in significant reductions in fatigue severity scores, suggesting that the observed improvements may be influenced by a strong placebo effect, as there was no significant difference in efficacy between the two light therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial. Mateen, FJ., Vogel, AC., Kaplan, TB., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06261528

Study of Circadian Focused Light Therapy in Progressive ... The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action.

2. withpower.com withpower.com/trial/phase-1-multiple-sclerosis-chronic-progressive-4-2024-101a7

Light Therapy for Multiple Sclerosis (NO-FATIGUE Trial) Light therapy is unique because it uses bright light exposure to help align sleep-wake and circadian rhythms, which may reduce fatigue in multiple sclerosis ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04054050

Bright Light Therapy for Sleep Disturbance in People With ... Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2017/09080/light_therapy_for_multiple_sclerosis_associated.52.aspx

Light therapy for multiple sclerosis-associated fatigue:... We hypothesize that supplemental exposure to bright white light may be beneficial in MS-associated fatigue and improve the quality of life of pMS. 2 Methods.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9841388/

Therapeutic Effects of Photobiomodulation Therapy on ... Results: PBM has positive effects on MS by regulating the inflammatory process, controlling immune cell activity and mitochondrial functions, as well as ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT06261528

Study of Circadian Focused Light Therapy in Progressive ... The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06261528/study-of-circadian-focused-light-therapy-in-progressive-multiple-sclerosis

Study of Circadian Focused Light Therapy in Progressive ... The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its ...

8. neurologylive.com neurologylive.com/view/innovative-trial-test-effect-light-therapy-progressive-ms-related-fatigue

Innovative Trial to Test Effect of Light Therapy on ... NO-FATIGUE study explores light therapy's safety and biomarkers to alleviate fatigue in progressive MS by synchronizing circadian rhythms. The ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425005901

Effectiveness and Safety of Bright Light Therapy in ... Bright light therapy is considered a well-tolerated and easy to administer form of treatment with relatively low costs. Our systematic review is focused on the ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6392596/

Light therapy for multiple sclerosis-associated fatigue We present a study design and rationale for randomizing a nonpharmacological intervention for MS-associated fatigue, using bright light therapy.