Cerebral HemodynamicsEPOCHNCT03944993
Effects of Pulsed Electromagnetic Fields (PEMFS) On Cerebral Haemodynamics
A study testing Pulsed Electromagnetic Fields Therapy (Dominant leg) and Pulsed Electromagnetic Fields Therapy (Non-dominant leg) in people with Cerebral Hemodynamics and Cognitive Change, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The investigators are looking to determine the effects of PEMFs device on cerebral blood flow and cognition in healthy volunteers. Through in vitro tests and in vivo animal studies, the investigators have shown that at an extremely low flux density (strength) of 1 millitesla (mT) and with short exposures of 10 minutes… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Hemodynamics, Cognitive Change
- What is being tested?
- Pulsed Electromagnetic Fields Therapy (Dominant leg) and Pulsed Electromagnetic Fields Therapy (Non-dominant leg)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Oct 2019to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 21- 65 years
- Ability to provide informed consent
Who cannot join
- Received any investigational drug or device within 30 days prior to study baseline visit or is enrolled in another clinical trial
- History of cardiac, neurological, or rheumatic diseases
- History of malignancy within the past 5 years
- Undergone surgery of any type within the past 6 months
- Anticipated need for surgery of any type during the next 3 months
- Previous treatment with the study device
Show all 11Show fewer
- Metal implants in the lower limb
- Existing or planned pregnancy
- Lactating women
- Leg circumference > 63 cm
- Colour vision deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pulsed Electromagnetic Fields (PEMFS) On Cerebral Haemodynamics - EPOCH Study
The investigators are looking to determine the effects of PEMFs device on cerebral blood flow and cognition in healthy volunteers. Through in vitro tests and in vivo animal studies, the investigators have shown that at an extremely low flux density (strength) of 1 millitesla (mT) and with short exposures of 10 minutes a week, PEMFs can recapitulate many of the healthful benefits of exercise without imparting a mechanical stress on the tissues and cells.
In the first-in-man study, 10 healthy volunteers were exposed to PEMFs for 6 weeks with 10 minutes of field exposure per week, and experienced an average increase of 30% in leg strength. No side effects were reported.
In this study, the investigators aim to understand the cerebral effects of an exercise mimetic (PEMFs) via the muscle milieu.
Read the detailed description
Human and animal studies have reported the beneficial influence of exercise on cognitive and brain functions. Accordingly, exercise is drawing increasing research attention as a possible lifestyle factor for improving neurocognitive functions.
Low frequency and low amplitude Pulsed Electromagnetic Fields (PEMFs) recapitulate many of the benefits of exercise by activating many of the same cellular second messenger cascades activated by mechanical input (exercise) yet, without imparting a physical stress on the cells. Through a series of in vitro and in vivo experiments the investigators have shown that at field strengths of 1-2 mT amplitude, the PEMF system stimulates muscle without physically stressing the tissues and delivers the following benefits: 1) slows muscle loss, 2) improves muscle strength and, 3) releases important regenerative and metabolism-enhancing agents.
Functional near-infrared spectroscopy (fNIRS) is a relatively new optical imaging technology that uses light in the near-infrared spectrum to non-invasively monitor the haemodynamic responses evoked by neural activity through measuring the changes in oxyhaemoglobin (HbO) and deoxyhaemoglobin (HbR) concentrations in the cerebral cortex. The increased blood supply to the area of neural activation typically results in an increase in HbO concentration while a decrease is observed in HbR due to the blood's washout effect. The HbO and HbR responses from fNIRS measurements have been shown to be spatially and temporally correlated with the blood oxygen level-dependent signal obtained by fMRI. The advantage of fNIRS over other imaging modalities is that it is inexpensive, non-invasive, non-ionising and portable, making it a highly popular modality for implementing brain-computer interfaces. OBELAB NIRSIT is a commercially available, high-density fNIRS device that optically measures haemodynamic variations in the pre-frontal cortex (PFC).
Low-frequency and low amplitude pulsed electromagnetic fields (PEMFs) recapitulate many of the healthful benefits of exercise by activating many of the same cellular second messenger cascades activated by mechanical input (exercise) yet, without imparting a physical stress on the cells. Response windows are a largely unrecognised rule in mechanobiological systems, whereby cells are most responsive to a given strain, duration and frequency of stimulation; greater strain of higher frequency and duration of stimulation is too much of a stress for cells and results in null responses.
The investigators have shown that PEMFs likewise obey an electromagnetic window of efficacy with temporal and frequency dependencies of similar scale as those required for mechanical stimulation, further supporting the conclusion that PEMFs are activating cellular mechanotransduction pathways. At field strengths of 1-2 mT amplitude, the PEMF system stimulates muscle without physically stressing the tissues and aims to deliver the following benefits: 1) slows muscle loss; 2) improves muscle strength and; 3) releases important regenerative and metabolism-enhancing agents. Accordingly, this study will investigate the exercise mimetic effects of PEMFs on cerebral haemodynamics and cognitive performance via targeting muscle. The results of this study will support future work with patients with memory deficits, such as mild cognitive impairment, to possibly mitigate disease progression.
- Conditions
- Cerebral Hemodynamics, Cognitive Change
- Being tested
- Pulsed Electromagnetic Fields Therapy (Dominant leg), Pulsed Electromagnetic Fields Therapy (Non-dominant leg), Sham Therapy (Control)
- Keywords
- PEMF, Prefrontal cortex, Exercise mimetic, Pulsed Electromagnetic Fields
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Fields Therapy (Dominant leg)Device
Also called PEMF, MRegen
Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak.
Pulsed Electromagnetic Fields Therapy (Non-dominant leg)Device
Also called PEMF, MRegen
Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their non-dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak.
Sham Therapy (Control)Device
Participants of this arm will be not be exposed to the fields. Sham treatment will utilise the same PEMF apparatus for 10 minutes, but in non-operational mode, which is indistinguishable from when the apparatus is in operation. Duration of intervention is 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Electromagnetic Field Therapy (Dominant leg) | Experimental | Active Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes on dominant leg. Receives: Device: Pulsed Electromagnetic Fields Therapy (Dominant leg) |
| Pulsed Electromagnetic Field Therapy (Non-dominant leg) | Experimental | Active Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes on non-dominant leg. Receives: Device: Pulsed Electromagnetic Fields Therapy (Non-dominant leg) |
| Sham Therapy (Control) | Sham comparator | Inactive Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes. Receives: Device: Sham Therapy (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral haemodynamic responses
The frontal lobe activity of the participants will be measured pre- and post-PEMF stimulation. We will then use the modified Beer-Lambert law (MBLL) to extract haemodynamics data from that signal after applying filtering to reject noise. Haemodynamics data of the three treatment groups will be incorporated into regression analysis. The amplitude of the signal will be further normalised by dividing the averaged values by the standard deviation during the first 10 seconds before task onset. The coordinates of the head landmarks and probe positions will be used to estimate the centroid position of each channel in the Montreal Neurological Institute standard brain space. We will calculate the Area Under Curve (AUC) of the waveform of averages and normalised HbO and HbR during the task. The AUC values of the fNIRS signals between pre- and post-PEMF stimulation in the PFC will be compared by paired t-tests to confirm changes.
Measured: Baseline and Week 7
Change in cognitive performance
To determine any cognitive improvement as a result of PEMF from baseline using Stroop task.
Measured: Baseline and Week 7
Secondary outcomes (2)
Quadriceps muscle strength
To determine the extent leg dominancy affects PEMF response in muscles i.e. percentage increase in quadriceps strength compared to baseline.
Measured: Baseline and Week 7
Thigh girth
To determine the extent leg dominancy affects PEMF response in muscle, we will measure participants' thigh girth (cm) 5 cm above from the superior border of the patella.
Measured: Baseline and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start22 Oct 2019
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Why it stopped: Premature termination due to logistical limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemodynamicsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a double-blinded, randomised, controlled pilot study. As a pilot study, 33 healthy adults will be enrolled and randomised into the intervention or sham arm at 2:1 ratio. Within the intervention arm, 50% of the participants will receive PEMFs in the non-dominant leg and the remaining 50% will receive intervention in the dominant leg (n = 11, 11). There are no restrictions based on race or gender.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Alfredo Franco-Obregon, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944993
- Sponsor's protocol ID
- EPOCH1.0
- Acronym
- EPOCH
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parate D, Franco-Obregon A, Frohlich J, Beyer C, Abbas AA, Kamarul T, Hui JHP, Yang Z. Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep. 2017 Aug 25;7(1):9421. doi: 10.1038/s41598-017-09892-w.
PubMed 28842627Crocetti S, Beyer C, Schade G, Egli M, Frohlich J, Franco-Obregon A. Low intensity and frequency pulsed electromagnetic fields selectively impair breast cancer cell viability. PLoS One. 2013 Sep 11;8(9):e72944. doi: 10.1371/journal.pone.0072944. eCollection 2013.
PubMed 24039828
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulsed Electromagnetic Fields (PEMFS) On Cerebral Haemodynamics - EPOCH Study
- ClinicalTrials.gov ID
- NCT03944993
- Acronym / sponsor ID
- EPOCH / EPOCH1.0
- Conditions
- Cerebral Hemodynamics, Cognitive Change
- Keywords
- PEMF, Prefrontal cortex, Exercise mimetic, Pulsed Electromagnetic Fields
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination due to logistical limitations.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are looking to determine the effects of PEMFs device on cerebral blood flow and cognition in healthy volunteers. Through in vitro tests and in vivo animal studies, the investigators have shown that at an extremely low flux density (strength) of 1 millitesla (mT) and with short exposures of 10 minutes a week, PEMFs can recapitulate many of the healthful benefits of exercise without imparting a mechanical stress on the tissues and cells.
In the first-in-man study, 10 healthy volunteers were exposed to PEMFs for 6 weeks with 10 minutes of field exposure per week, and experienced an average increase of 30% in leg strength. No side effects were reported.
In this study, the investigators aim to understand the cerebral effects of an exercise mimetic (PEMFs) via the muscle milieu.
Detailed description
Human and animal studies have reported the beneficial influence of exercise on cognitive and brain functions. Accordingly, exercise is drawing increasing research attention as a possible lifestyle factor for improving neurocognitive functions.
Low frequency and low amplitude Pulsed Electromagnetic Fields (PEMFs) recapitulate many of the benefits of exercise by activating many of the same cellular second messenger cascades activated by mechanical input (exercise) yet, without imparting a physical stress on the cells. Through a series of in vitro and in vivo experiments the investigators have shown that at field strengths of 1-2 mT amplitude, the PEMF system stimulates muscle without physically stressing the tissues and delivers the following benefits: 1) slows muscle loss, 2) improves muscle strength and, 3) releases important regenerative and metabolism-enhancing agents.
Functional near-infrared spectroscopy (fNIRS) is a relatively new optical imaging technology that uses light in the near-infrared spectrum to non-invasively monitor the haemodynamic responses evoked by neural activity through measuring the changes in oxyhaemoglobin (HbO) and deoxyhaemoglobin (HbR) concentrations in the cerebral cortex. The increased blood supply to the area of neural activation typically results in an increase in HbO concentration while a decrease is observed in HbR due to the blood's washout effect. The HbO and HbR responses from fNIRS measurements have been shown to be spatially and temporally correlated with the blood oxygen level-dependent signal obtained by fMRI. The advantage of fNIRS over other imaging modalities is that it is inexpensive, non-invasive, non-ionising and portable, making it a highly popular modality for implementing brain-computer interfaces. OBELAB NIRSIT is a commercially available, high-density fNIRS device that optically measures haemodynamic variations in the pre-frontal cortex (PFC).
Low-frequency and low amplitude pulsed electromagnetic fields (PEMFs) recapitulate many of the healthful benefits of exercise by activating many of the same cellular second messenger cascades activated by mechanical input (exercise) yet, without imparting a physical stress on the cells. Response windows are a largely unrecognised rule in mechanobiological systems, whereby cells are most responsive to a given strain, duration and frequency of stimulation; greater strain of higher frequency and duration of stimulation is too much of a stress for cells and results in null responses.
The investigators have shown that PEMFs likewise obey an electromagnetic window of efficacy with temporal and frequency dependencies of similar scale as those required for mechanical stimulation, further supporting the conclusion that PEMFs are activating cellular mechanotransduction pathways. At field strengths of 1-2 mT amplitude, the PEMF system stimulates muscle without physically stressing the tissues and aims to deliver the following benefits: 1) slows muscle loss; 2) improves muscle strength and; 3) releases important regenerative and metabolism-enhancing agents. Accordingly, this study will investigate the exercise mimetic effects of PEMFs on cerebral haemodynamics and cognitive performance via targeting muscle. The results of this study will support future work with patients with memory deficits, such as mild cognitive impairment, to possibly mitigate disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The study is designed as a double-blinded, randomised, controlled pilot study. As a pilot study, 33 healthy adults will be enrolled and randomised into the intervention or sham arm at 2:1 ratio. Within the intervention arm, 50% of the participants will receive PEMFs in the non-dominant leg and the remaining 50% will receive intervention in the dominant leg (n = 11, 11). There are no restrictions based on race or gender.
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electromagnetic Field Therapy (Dominant leg) | Experimental | Device: Pulsed Electromagnetic Fields Therapy (Dominant leg)Active Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes on dominant leg. |
| Pulsed Electromagnetic Field Therapy (Non-dominant leg) | Experimental | Device: Pulsed Electromagnetic Fields Therapy (Non-dominant leg)Active Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes on non-dominant leg. |
| Sham Therapy (Control) | Sham comparator | Device: Sham Therapy (Control)Inactive Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 21- 65 years
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- Received any investigational drug or device within 30 days prior to study baseline visit or is enrolled in another clinical trial
- History of cardiac, neurological, or rheumatic diseases
- History of malignancy within the past 5 years
- Undergone surgery of any type within the past 6 months
- Anticipated need for surgery of any type during the next 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Fields Therapy (Dominant leg)Also: PEMF, MRegenParticipants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed. The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak. | Device | Pulsed Electromagnetic Field Therapy (Dominant leg) |
| Pulsed Electromagnetic Fields Therapy (Non-dominant leg)Also: PEMF, MRegenParticipants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their non-dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed. The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak. | Device | Pulsed Electromagnetic Field Therapy (Non-dominant leg) |
| Sham Therapy (Control)Participants of this arm will be not be exposed to the fields. Sham treatment will utilise the same PEMF apparatus for 10 minutes, but in non-operational mode, which is indistinguishable from when the apparatus is in operation. Duration of intervention is 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed. | Device | Sham Therapy (Control) |
Primary outcome
Change in cerebral haemodynamic responses
Time frame: Baseline and Week 7
The frontal lobe activity of the participants will be measured pre- and post-PEMF stimulation. We will then use the modified Beer-Lambert law (MBLL) to extract haemodynamics data from that signal after applying filtering to reject noise. Haemodynamics data of the three treatment groups will be incorporated into regression analysis. The amplitude of the signal will be further normalised by dividing the averaged values by the standard deviation during the first 10 seconds before task onset. The coordinates of the head landmarks and probe positions will be used to estimate the centroid position of each channel in the Montreal Neurological Institute standard brain space. We will calculate the Area Under Curve (AUC) of the waveform of averages and normalised HbO and HbR during the task. The AUC values of the fNIRS signals between pre- and post-PEMF stimulation in the PFC will be compared by paired t-tests to confirm changes.
Change in cognitive performance
Time frame: Baseline and Week 7
To determine any cognitive improvement as a result of PEMF from baseline using Stroop task.
2 secondary outcomes
Quadriceps muscle strength
Time frame: Baseline and Week 7
Thigh girth
Time frame: Baseline and Week 7
Results and safety
The study was stopped early (reason given: Premature termination due to logistical limitations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Background: PubMed 28842627Parate D, Franco-Obregon A, Frohlich J, Beyer C, Abbas AA, Kamarul T, Hui JHP, Yang Z. Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep. 2017 Aug 25;7(1):9421. doi: 10.1038/s41598-017-09892-w.
- Background: PubMed 24039828Crocetti S, Beyer C, Schade G, Egli M, Frohlich J, Franco-Obregon A. Low intensity and frequency pulsed electromagnetic fields selectively impair breast cancer cell viability. PLoS One. 2013 Sep 11;8(9):e72944. doi: 10.1371/journal.pone.0072944. eCollection 2013.
- News article covering MRegenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Franco-Obregon principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Fields Therapy (Dominant leg) and Pulsed Electromagnetic Fields Therapy (Non-dominant leg) in people with Cerebral Hemodynamics and Cognitive Change, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Premature termination due to logistical limitations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral haemodynamic responses (time frame: Baseline and Week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03944993, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.