An interventional study of Photobiomodulation therapy in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by Quadram Institute Bioscience. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Treatment
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Among 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom — 4 open to participants now, 5 under way, none of them phase 3. Fatigue Syndrome, Chronic · United Kingdom.
Among the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom, this one is one of 2 that started in 2024, is one of 3 with no phase, and was the 8th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →4 of the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom are open now. Recruiting first, the newest first:
Oxford Brookes University · Sites in United Kingdom
Ages 18–80 · Healthy volunteers
King's College London · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18–99 · Healthy volunteers
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 10 is below the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 17 across the 4 interventional studies, 87 across the 6 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 9 most frequent:
Quadram Institute Bioscience is the lead sponsor of 44 studies on the registry; 6 are open to participants now.
Quadram Institute Bioscience has 1 study filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
1 of the studies in Fatigue Syndrome, Chronic with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07874217Oxford Brookes UniversityWhole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study | 2027-01-08 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies in Fatigue Syndrome, Chronic with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Intervention:
Follow-up:
Feedback:
The prevailing theory regarding mechanism of action of PBM is that by activating cytochrome c oxidase (CCO) it boosts mitochondrial ATP production, which, in turn, enhances the metabolic activity of the cell. This occurs simultaneously with the regulation of the reduction/oxidation (redox) state of the intracellular microenvironment favouring expression of genes associated with tissue regeneration and repair. Immune modulation and dampening or attenuation of pro-inflammatory responses ensures a coordinated regenerative effort. An alternate mechanism of action, independent of the absorption of red and near infrared light by CCO, proposes that by reducing the viscosity of interfacial water layers in the predominantly hydrophilic intramitochondrial space PBM increases the speed of rotation and activity of the mitochondrial rotary motor (ATP synthase) that results in increased ATP production. Irrespective of the exact biochemical mechanism of action, crucially, these processes take place in the absence of inciting tissue injury, photothermal effects, or photoacoustic effects.
While the underlying causes of ME/CFS are not know a consistent finding from metabolism-based studies is mitochondrial dysfunction and compromised energy metabolism characterised by high levels of oxidative stress and limited ATP production. Loss of mitochondrial function and compromised ATP production is therefore a plausible explanation for the debilitating chronic fatigue that defines ME/CFS. Based upon prior human studies demonstrating restored ATP production and function investigators hypothesise that PBM and 670nm red light exposure will, by increasing mitochondrial function in ME/CFS patients, improve their physical capacity and cognitive function.
The device that will be used to evaluate red light therapy in ME/CFS patients is an LED lamp that emits a spectrum of light in the red spectrum of visible light, peaking at 670 nm. This lamp was purchased from Planet Lighting Ltd, London, UK; LBT-PAR38-40. This lamp has the following specifications: 1) 40W output, 2) 60o beam angle, 3) 220-240V 50Hz input, 4) E27 base, 5) has a UK Conformity Assessed (UKCA) marking, 6) has CE certification, 7) is Restriction of Hazardous Substances Directive (RoHS) compliant, 8) has a 3 years warranty. It is important to note that this is not a medical device and will be marketed by Planet Lighting as an aid to general health wellbeing lamp for the general population. The Planet Lighting website advertising this product is currently being developed. The director from Planet Lighting has confirmed this in a letter.
Participants will be identified through the UK charity Invest in ME Research. Potential participants are those who have subscribed to the charity. The charity will email subscribers the study flyer and the participant invitation letter. The study flyer and participant invitation letter will include a link to the study specific website on Mantal. The homepage of the study website will contain a summary of the study and a link to the full participant information sheet which ME patients can either download and print or read online.
At the end of the full participant information sheet participants will be instructed on how to provide their informed consent if they wish to participate. Participants will be asked to click on the "register now" button on the homepage of the study website. When participants click on the register now button they will be taken through a series of statements for their consent. If participants consent to all of the statements they will then be taken to a sign up page where participants are able to register for the study with their first and last name and email address. They will be asked to provide a password for their account.
After participants have provided informed consent and created an account on the study website participants will be asked to complete a screening questionnaire on the study website. Participants who fulfil the eligibility criteria will receive a notification to inform them that they are eligible and have been enrolled onto the study. The notification also prompts participants to log in to Mantal to complete baseline study procedures. Participants who do not fulfil the eligibility criteria will be notified on the screen that they are unable to participate in the study at this time and will receive a QIB withdrawal letter via email.
Once participants are enrolled onto the study, participants will be asked to complete the "About You" questionnaire, which will collect information on the participants demographics and ME diagnosis.
Then participants will move onto baseline measures. The first baseline measure participants are asked to complete is the FUNCAP27 questionnaire, which assesses functional capacity. Participants will complete the FUNCAP27 questionnaire online through Mantal. Once participants have completed this questionnaire, they will then complete the battery of six online cognitive function assessments from NeurOn (https://neuropsychology.online) in the following order: 1) reaction time, 2a) word encoding, 2b) word retrieval, 3) trails A, 4) trails B, 5) digit span backwards and 6) fragmented letters. Participants will complete cognitive assessments online through Mantal. Participants can choose to either complete the FUNCAP27 questionnaire and the cognitive function assessments on the same day or on separate days. Participants are asked to try to complete as many of the cognitive function assessments as they feel able to. Before and after each cognitive function assessment participants are asked to rate their level of cognitive fatigue (from 1 to 10, 1 being the worst and 10 being the best) and asked if they feel well enough to complete the next cognitive function assessment. If participants answer no, then the battery of cognitive function assessments will be terminated for that participant. Participants will receive daily text or email reminders to complete the FUNCAP27 and NeurOn assessments. After participants have completed or terminated the cognitive function assessments they will be asked to provide their address for the research team to mail the GENEActiv wrist worn accelerometer monitor and instructions to participants. Participants will be asked to complete an equipment disclaimer form online prior to wearing the accelerometer. Participants will be asked to wear these monitors immediately upon receipt for a total of seven days. Participants will receive daily automatic text reminders sent out by Mantal to wear the monitor. Participants are asked to enter the date they start wearing the monitor onto the study portal. Once participants have confirmed they are wearing the monitor, participants will be able to complete the morning and evening entries of the consensus sleep diary version E (CSD-E) for the seven days they are wearing the monitor. Participants will receive daily text reminders (automatically sent out by Mantal) to complete the CSD-E morning and evening entries. Seven days from the date they start wearing the monitor participants will receive a text reminder (automatically sent out by Mantal) to take off the monitors and to post them back to the research team using the prepaid envelope. Participants who are housebound are asked to contact the research team to arrange a courier to collect the GENEActiv accelerometer from participants homes. Participants will receive a text reminder daily until the research team has received the monitor. The PI will download the raw data from the devices internal memory and perform a quality control (QC) check that the monitor has worked and recorded activity for 7 days. If the monitor has not worked participants will be requested to repeat the wear of the monitor and completing the CSD-E.
Once the activity monitor data has passed the QC the red lamp (Planet Lighting Ltd, London, UK) will be posted to participants with instructions for use. Participants will complete an online donated equipment disclaimer form before using the lamps. Participants will be asked to use this lamp for 2 minutes, daily (between 9:00 and 11:00), for a total of 2 weeks. Participants will receive daily text reminders at 8:30 to use the lamp. Participants will be asked to log on to mantal each day and record whether they have managed to use the lamp that day. After using the lamp for 2 weeks participants will be asked to return the lamp back to the research team using the prepaid postage labels. Participants who are housebound are asked to contact the research team to arrange a home collection via courier.
Once participants have finished the intervention, they are asked to complete the FUNCAP27 questionnaire, NeurOn assessments, wear the GENEActiv monitor and the complete the CSD-E. This will be undertaken following the same protocol as the baseline measures. Once the research team has received the monitors in the post participants will be asked to complete a feedback questionnaire via Mantal.
The end of the study will be when the last participant has completed the feedback questionnaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will use the 670 nm lamp for 2 minutes each morning for 14 days.
Other: Photobiomodulation therapy
deep red light therapy (670nm)
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 3, 4, and 7
Compliance of the GENEActiv accelerometers in ME patients
Compliance will be measured with daily completion of the consensus sleep diary version E during the 7-day intervention at week 2.
Time frame: Week 2
Acceptance of the GENEActiv accelerometers in ME patients
Acceptance will be measured at week 2 when participants initially sign into Mantal study portal at the start of intervention and at week 7 with the Feedback questionnaire which will ask about ease of wearing the accelerometer. The responses are binary (YES or NO). Greater number of YES responses compared to NO responses will indicate that the GENEActiv accelerometers was acceptable in ME patients.
Time frame: Week 2 and week 7
Safety of GENEActiv accelerometers in ME patients.
Self-reported adverse reaction or event by participants to the accelerometer. Safety will be measured at week 2 (during intervention), at week 6 (follow-up phase) 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. GENEActiv accelerometers in ME patients will be regarded safe when severity of self-reported adverse reaction is no greater than mild in severity.
Time frame: Week 2, 6, and 7
Changes in NeurOn (online cognitive function assessments) completion rates in ME patients.
Comparison of the completion rates in NeurOn will be assessed at baseline (week 1) and follow up visit (week 5).
Time frame: Week 1 and 5
Acceptability of NeurOn in ME patients.
Feedback questionnaire at week 7 regarding NeurON (online cognitive function assessments) will be used to measure the ease of using an online cognitive function test and the acceptability of the number of assessments that were administered during the study.
Time frame: Week 7
Acceptability of FUNCAP27 in ME patients.
Feedback questionnaire at week 7 regarding FUNCAP27 (quantitative assessment of functional capacity) will be use to measure the acceptability of the length of FUNCAP27 assessment and ability to understand the questions in FUNCAP27.
Time frame: Week 7
Compliance of the consensus sleep diary version E (CSD-E) in ME patients.
Number of completed daily sleeping diaries submitted during the 7 day intervention (week 2)
Time frame: Week 2
Acceptability of the consensus sleep diary version E (CSD-E) in ME patients.
Feedback questionnaire at week 7 regarding consensus sleep diary version E will be used to measure the acceptability by assessing the ease of use and frequency of sleep diary documentation (day and evenings).
Time frame: Week 7.
Acceptability of Mantal in ME patients.
Feedback questionnaire at week 7 regarding Mantal (online study and participant management tool) will be used to measure acceptability by assess the ease of using Mantal study portal and use of online informed consent procedure, and the notifications sent by Mantal.
Time frame: week 7
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Aug 2024, 3 months after the start.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Quadram Institute Bioscience