The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
Recruiting · NCT07306104 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern Denmark
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Cancer in the brain, neck, or head area
- Presence of active medical implants
- Epilepsy
- Alcoholism
- Substance abuse
- Open wound on the scalp
- Severe psychopathological disorders
- Pregnancy
- Changes in pharmacological anti-Parkinson medication within the last 6 weeks prior to the start of T-PEMF treatment
- Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep
- Neurological disease other than Parkinson's disease
- Previous stroke
- Reduced motor function caused by conditions other than Parkinson's disease
- Control Group with Parkinson's Disease
- Inclusion Criteria:
- Diagnosed with idiopathic Parkinson's disease
- The patient 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
- Exclusion Criteria:
- Neurological disease other than Parkinson's disease
- Reduced motor function caused by conditions other than Parkinson's disease
- Healthy Reference Group:
- Inclusion Criteria:
- The patient must be able to understand, accept, and complete the planned procedures
- Exclusion Criteria:
- Neurological disease
- Reduced motor function caused by condition
Where it is running
2 locations listed.
- Odense University Hospital - Odense, Denmark
- University of Southern Denmark - Odense, Denmark