The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are:
* How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease? * How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake?
The neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake.
Participants in the intervention group will:
* receive one 30 min treatment session daily for 12 months * receive either T-PEMF or sham treatment for the first 6 months * receive active T-PEMF treatment the last 6 months * visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.
Diagnosed with idiopathic Parkinson's disease
The participant must be able to understand, accept, and complete the planned procedures
Parkinson's symptoms in the medicated state must correspond to Hoehn & Yahr stage 1 or 2
Mini Mental-State Examination score > 22
Cancer in the brain, neck, or head area
Presence of active medical implants
Epilepsy
Alcoholism
Parallel
Transcranial pulsed electromagnetic fields (T-PEMF)
Device30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham (No Treatment)
Device30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Sit-to-stand
Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.
Tremor intensity
Postural tremor intensity assessed by accelerometer
Rate of force development
Isometric rate of force development assessed by handgrip and knee extension
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS will be reported as total score (0-260, higher scores indicate greater disease severity) and motor score (part III, 0-132, higher scores indicate greater disease severity).
Cerebrospinal fluid biomarkers
Concentration of growth factors, cytokines and cytoskeletal proteins with special emphasis on erythropoietin (EPO), vascular endothelial growth factor (VEGF), brain-derived neutrophic factor (BDNF), glia cell derived neutrophilic factor (GDNF), Glucagon Like Peptide 1 (GLP1), interleukins and neurofilament light chain (NfL).
EMG
Electromyographic recordings of forearm and thigh muscles during motor assessments (sit-to-stand, isometric contractions, postural tremor assessment, handwriting). Applied for explorative analyses, thus exact outcomes are not yet specified. However, agonist drive and co-contraction ratio may be assessed.
Hand writing
Hand writing test performed with ink pen on paper on top of tablet (digitalizing handwriting). Performed as an explorative assessment.
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University of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Bente & Erik Schøller Larsens Foundation
Collaborator
