Modulation of Long-Term Potentiation-Like Cortical Plasticity in the Healthy Brain With Low Frequency-Pulsed Electromagnetic Fields
Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs) have shown the ability to modulate living structures, principally by influencing synaptic activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was presented as a molecular accelerator, using energy up to 200 Joules and providing high-power (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy subjects without known neurological and/or psychiatric diseases entered the study. A randomized double-blind sham-controlled crossover design was employed, recording TMS parameters (amplitude variation of the motor evoked potential as index of cortical excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30 min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15 minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30 min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.
NCT03537469 — Transcranial Magnetic Stimulation
Status: Completed
http://inclinicaltrials.com/transcranial-magnetic-stimulation/NCT03537469/
PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.
NCT03394547 — Dysmenorrhea
Status: Recruiting
http://inclinicaltrials.com/dysmenorrhea/NCT03394547/
A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction
This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.
NCT03165318 — Muscle Loss Post Anterior Cruciate Ligament Reconstruction
Status: Enrolling by invitation
http://inclinicaltrials.com/muscle-loss-post-anterior-cruciate-ligament-reconstruction/NCT03165318/
The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain
This study will examine the effects of a portable of pulsed electromagnetic field (PEMF) device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of pain and function in patients with either acute/subacute or chronic low back pain (LBP).
NCT03053375 — Low Back Pain
Status: Recruiting
http://inclinicaltrials.com/low-back-pain/NCT03053375/
A Multicentric, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effectiveness of Low-frequency Pulsed Electromagnetic Fields (ELF-MF) in Acute Ischemic Stroke
The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients. 124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke. The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.
NCT02767778 — Ischemic Stroke
Status: Terminated
http://inclinicaltrials.com/ischemic-stroke/NCT02767778/
Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
The objectives are to evaluate impact of Pulsed electromagnetic field (PEMF) therapy on patients with Post-Concussive Syndrome with Rivermead Post Concussion Symptom Questionnaire (RPQ) as a primary outcome, followed by fatigue and mood as second and tertiary outcomes respectively. The investigators will also investigate brain tissue activity and oxygenation by evaluating brain wave activity via non-invasive quantitative electroencephalogram and near infrared spectroscopy testing pre and post study to better understand the metabolic effect of the PEMF intervention. The investigators hypothesize that the PEMF treatment will have an effect on improvement of brain metabolism as measured by Near Infrared Spectroscopy which will in turn assist with improvement of the chronic symptoms of cognitive deficits, mood and fatigue as related to Post-Concussive Syndrome.
NCT02643836 — Concussion
Status: Withdrawn
http://inclinicaltrials.com/concussion/NCT02643836/
Evaluation of Postoperative Edema and Pain Following Third Molar Extraction With Application of Pulsed Electromagnetic Field (PEMF) Therapy
This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of impacted third molars. The study group will be comprised of subjects that will receive PEMF Actiband treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema. Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until 60 qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the Actiband and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.
NCT02376946 — Postoperative Edema and Pain
Status: Terminated
http://inclinicaltrials.com/postoperative-edema-and-pain/NCT02376946/
Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
A double-blinded randomized control study using a pulsed electromagnetic field therapy to establish whether this device decreases patient pain and decreases narcotic use in women who have undergone cesarean delivery.
NCT02365753 — Postoperative Pain
Status: Completed
http://inclinicaltrials.com/postoperative-pain/NCT02365753/
Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process
The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.
NCT02281994 — Odontoid Fracture Type II
Status: Terminated
http://inclinicaltrials.com/odontoid-fracture-type-ii/NCT02281994/
Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
This randomized clinical trial was designed to assess the clinical efficacy of Pulsed electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction. The sample included 120 patients undergoing unilateral mandibular third molar extraction. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.
NCT02273999 — Pain
Status: Completed
http://inclinicaltrials.com/pain/NCT02273999/