Effects of Pulsed Electromagnetic Fields (PEMFS) On Cerebral Haemodynamics

NCT03944993 | Terminated DMC

• 1 other identifier: EPOCH1.0
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cerebral Hemodynamics; Cognitive Change

Keywords

PEMF; Prefrontal cortex; Exercise mimetic; Pulsed Electromagnetic Fields

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Week 7

• Change in cognitive performance

  To determine any cognitive improvement as a result of PEMF from baseline using Stroop task.

  Baseline and Week 7

Secondary Outcomes (2)

• Quadriceps muscle strength

  Baseline and Week 7

• Thigh girth

  Baseline and Week 7

Study Arms (3)

Pulsed Electromagnetic Field Therapy (Dominant leg)

EXPERIMENTAL

Active Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes on dominant leg.

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.

Device: Pulsed Electromagnetic Fields Therapy (Non-dominant leg)

Sham Therapy (Control)

SHAM COMPARATOR

Inactive Pulsed Electromagnetic Field therapy; exposed once weekly for 10 minutes.

Device: Sham Therapy (Control)

Interventions

Pulsed Electromagnetic Fields Therapy (Dominant leg) DEVICE

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.

Also known as: PEMF, MRegen

Pulsed Electromagnetic Field Therapy (Dominant leg)

Pulsed Electromagnetic Fields Therapy (Non-dominant leg) DEVICE

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.

Also known as: PEMF, MRegen

Pulsed Electromagnetic Field Therapy (Non-dominant leg)

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.

Sham Therapy (Control)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21- 65 years
• Ability to provide informed consent

You may not qualify if:

• 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
• Metal implants in the lower limb
• Existing or planned pregnancy
• Lactating women
• Leg circumference \> 63 cm
• Colour vision deficiency

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

• 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.

  PMID: 28842627 BACKGROUND

• Crocetti 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.

  PMID: 24039828 BACKGROUND

Related Links

• News article covering MRegen

Study Officials

• Alfredo Franco-Obregon

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: October 22, 2019
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: July 1, 2021

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)