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

RECRUITINGN/ASponsored by University of Southern Denmark
Actively Recruiting
PhaseN/A
SponsorUniversity of Southern Denmark
Started2026-02-01
Est. completion2028-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
Intervention Groups

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

Conditions2

PARKINSON DISEASE (Disorder)Parkinson's Disease

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