RecruitingNot ApplicableNCT07306104

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

The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF


Sponsor

University of Southern Denmark

Enrollment

90 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria10

  • Intervention Groups
  • 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
  • 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
  • The patient must be able to understand, accept, and complete the planned procedures

Exclusion Criteria19

  • 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
  • Neurological disease other than Parkinson's disease
  • Reduced motor function caused by conditions other than Parkinson's disease
  • Healthy Reference Group:
  • Neurological disease
  • Reduced motor function caused by condition

Interventions

DEVICETranscranial pulsed electromagnetic fields (T-PEMF)

30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)

DEVICESham (No Treatment)

30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs


Locations(2)

Odense University Hospital

Odense, Denmark

University of Southern Denmark

Odense, Denmark

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NCT07306104


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