Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145867
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2023-10-04
Brief Title:
A Feasibility Study Assessing Photobiomodulation in Myalgic Encephalomyelitis
Sponsor:
Quadram Institute Bioscience
Organization:
Quadram Institute Bioscience
Study Overview
Official Title:
A Feasibility Study Assessing the Acceptability Adherence and Safety of Photobiomodulation PBM Therapy and Objective Assessment Measures in Myalgic Encephalomyelitis ME
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LightMEup
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 reductionincrease 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 reductionincrease
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
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 reductionincrease 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 reductionincrease
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
Detailed 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 reductionoxidation 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 MECFS 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 MECFS 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 MECFS patients improve their physical capacity and cognitive function
The device that will be used to evaluate red light therapy in MECFS 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 httpsneuropsychologyonline 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 900 and 1100 for a total of 2 weeks Participants will receive daily text reminders at 830 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
While the underlying causes of MECFS 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 MECFS 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 MECFS patients improve their physical capacity and cognitive function
The device that will be used to evaluate red light therapy in MECFS 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 httpsneuropsychologyonline 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 900 and 1100 for a total of 2 weeks Participants will receive daily text reminders at 830 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None