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

Trial Summary

What is the purpose of this trial?

The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. 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. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.

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 data supports the effectiveness of light therapy for multiple sclerosis?

There is no direct evidence from the provided research articles supporting the effectiveness of light therapy specifically for multiple sclerosis. However, exercise and rehabilitation have shown benefits in improving fitness and function for those with MS, suggesting that therapies focusing on physical and psychological well-being may be beneficial. ^{1 2 3 4 5}

How is light therapy different from other treatments for multiple sclerosis?

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 patients. Unlike many treatments, it is non-pharmacological, meaning it doesn't involve drugs, and is considered safe with few side effects. ^{6 7 8 9 10}

Research Team

Peter Sguigna, MD

Principal Investigator

UTSW

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Measuring patient-centered outcomes in neurologic disease. Extending the Q-TWiST method. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Rehabilitation in multiple sclerosis]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Progress in neurorehabilitation in multiple sclerosis. [2019]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise and rehabilitation for individuals with multiple sclerosis. [2022]

6. France pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Bright light therapy as a non-pharmacological treatment option for multiple sclerosis-related fatigue: A randomized sham-controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Chronobiological regulation of psychosocial and physiological outcomes in multiple sclerosis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial. [2021]