About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Cancer in the brain, neck, or head area
Presence of active medical implants
Epilepsy
Alcoholism
Trial design
Treatments tested in this trial
- Transcranial pulsed electromagnetic fields (T-PEMF)
- Sham (No Treatment)
Treatment groups
Sponsors and collaborators
University of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Bente & Erik Schøller Larsens Foundation
Collaborator