Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Hemodynamics
  • Cognitive Change
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 65 years
Gender
Both males and females

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 F...

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.

Tracking Information

NCT #
NCT03944993
Collaborators
National University, Singapore
Investigators
Principal Investigator: Alfredo Franco-Obregon National University, Singapore