NCT06145867: LightMEup

A Feasibility Study: Assessing Photobiomodulation in Myalgic Encephalomyelitis

ENROLLING BY INVITATION NA Last updated 29 April 2024

What this trial tests

NA trial testing Photobiomodulation therapy in Myalgic Encephalomyelitis in 10 participants. Enrolling by invitation.

Timeline

24 April 2024

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	Quadram Institute Bioscience
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	24 April 2024
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Photobiomodulation therapy

Conditions studied

• Myalgic Encephalomyelitis — all drugs for Myalgic Encephalomyelitis →
• Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →

Sponsor

Quadram Institute Bioscience

Who can join

18 and older, any sex, with Myalgic Encephalomyelitis or Chronic Fatigue Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is no cure or approved treatments for ME. Several causes have been implicated in ME, including poor mitochondrial function. Mitochondria are the powerhouse of cells, producing energy. Therefore, loss of mitochondrial function and reduced energy production could be an explanation for the debilitating chronic fatigue that defines ME.

The primary site of red light absorption in cells is the mitochondria. Mitochondrial red light absorption can boost energy production. Light therapy is already FDA approved for the treatment of acne, muscle and joint pain, arthritis, blood circulation issues and hair loss. This is the first study to trial the use of red light therapy in ME and results will help us understand if the use of red light therapy is accepted by ME patients.

In past clinical trials the monitoring of symptom reduction/increase in ME patients was mainly done using symptom questionnaires. These questionnaires have not been specifically developed for ME symptoms and therefore the reliability of results is poor. This study will be assessing the use of a new symptom questionnaire developed specifically for ME and will also be trialling the use of other tools to measure symptom reduction/increase.

In addition, this study will also trial the use of Mantal, an online remote research management portal. This is to improve accessibility of ME patients to research participation.

Each ME participants involvement in the study should take approximately 7 weeks. Involvement is split into four phases: 1) baseline, 2) intervention, 3) follow-up and 4) feedback.

Baseline assessments:

* Week one: complete a 27-item questionnaire on functional capacity (FUNCAP27) and online cognitive function tests
* Week two: participants are posted an activity monitor which they are to wear for seven days. Participants will complete a sleep diary (consensus sleep diary version E) for seven days

Intervention:

\- Participants are posted the red lamp to use in their own homes during weeks three and four. Participants use the red lamp for two minutes, daily, each morning for a total of 14 days.

Follow-up:

* Weeks five and six
* Repeating the baseline assessments

Feedback:

\- Participants are asked to complete an online questionnaire during week seven.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): diagnosis and management.
   Fan J, Jiao J, Chang HQ, Zhong DL, et al · · 2025 · PMID 41366804 · DOI 10.1186/s12967-025-07506-y
2. Differences in the Effectiveness of Different Physical Therapy Modalities in the Treatment of Delayed-Onset Muscle Soreness: A Systematic Review and Bayesian Network Meta-Analysis.
   Chen J, Hu Q, Hu J, Liu S, et al · · 2025 · PMID 40538474 · DOI 10.2147/jpr.s519242