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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark

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

90 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Southern Denmark

Lead sponsor

Odense University Hospital

Collaborator

Bente & Erik Schøller Larsens Foundation

Collaborator