A Feasibility Study: Assessing Photobiomodulation in Myalgic Encephalomyelitis

Summary

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.

Conditions

• Myalgic Encephalomyelitis
• Chronic Fatigue Syndrome

Interventions

OTHER

Photobiomodulation therapy

deep red light therapy (670nm)

Sponsors & Collaborators

• University of East Anglia

  collaborator OTHER

• Quadram Institute Bioscience

  lead OTHER

Principal Investigators

• Simon Carding, PhD · Quadram Institute Bioscience

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-24

Primary Completion

2024-08-01

Completion

2024-08-01

Countries

• United Kingdom

Study Locations