Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06145867 |
| Other study ID # |
QIB02/2023 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 24, 2024 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Quadram Institute Bioscience |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
