The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcranial pulsed electromagnetic fields (T-PEMF): 30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)

Sham (No Treatment): 30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs

Study summary

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

Primary outcome measure(s)

• Sit-to-stand — From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
  Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.

Trial sites (2)

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