A Feasibility Study: Assessing Photobiomodulation in Myalgic Encephalomyelitis

NCT06145867 | Enrolling By Invitation

• 1 other identifier: QIB02/2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

me/cfs

Outcome Measures

Primary Outcomes (3)

• Compliance of PBM therapy in ME patients.

  Compliance will be measured when participants log in daily into Mantal study portal to confirm the use of the lamp during the 14 days from week 3 to 4.

  Week 3 and 4

• Acceptance of PBM therapy in ME patients.

  Acceptance will be measured at week 7 using the Feedback questionnaire which will ask about ease of setting up the red lamp (PBM), ease of use during the 14 day intervention and future use of lamp. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that PBM therapy was acceptable in ME patients.

  Week 7

• Safety of PBM therapy in ME patients.

  Self-reported adverse reaction or event by participants to the red (PBM) lamp will be used to measure safety. Safety will be measured at week 3 (start of intervention) through week 4 (at the end of intervention) and at week 7 (feedback questionnaire). The severity of the adverse event will be reported using the University of East Anglia and Norfolk and Norwich University Hospitals SOP 205 guidelines. Safety will be reported as mild, moderate, or severe. PBM therapy in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.

  Week 3, 4, and 7

Secondary Outcomes (9)

• Compliance of the GENEActiv accelerometers in ME patients

  Week 2

• Acceptance of the GENEActiv accelerometers in ME patients

  Week 2 and week 7

• Safety of GENEActiv accelerometers in ME patients.

  Week 2, 6, and 7

• Changes in NeurOn (online cognitive function assessments) completion rates in ME patients.

  Week 1 and 5

• Acceptability of NeurOn in ME patients.

  Week 7

Study Arms (1)

PBM therapy

EXPERIMENTAL

All participants will use the 670 nm lamp for 2 minutes each morning for 14 days.

Other: Photobiomodulation therapy

Interventions

Photobiomodulation therapy OTHER

deep red light therapy (670nm)

PBM therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have received an ME diagnosis from primary or secondary care
• must be able to understand the requirements of the study and provide informed consent.
• must live in the UK

You may not qualify if:

• Participants who have received one or more of the following diagnoses: 1) any illness other than ME/CFS that has fatigue as a symptom (e.g. multiple sclerosis or inherited mitochondrial disease), 2) any illness with cognitive defects (e.g. alzheimer's disease, dementia), 3) any proliferative disease (e.g. cancer), 4) any surface bacterial/fungal infection (e.g. blepharitis)
• Participants who have altered their medication within the last 4 weeks
• Participants who have made major dietary alterations within the last 4 weeks
• Participants who have underwent surgery requiring general anaesthetic within the last 6 months
• Participants who have broken/fractured/torn any bones or ligaments within the last 6 months
• Participants who are pregnant

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• University of East Anglia: collaborator

Study Sites (1)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Simon Carding, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 24, 2023
• Study Start: April 24, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)