Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07306104

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

Led by University of Southern Denmark · Updated on 2026-04-29

90

Participants Needed

2

Research Sites

97 weeks

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

O

Odense University Hospital

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with idiopathic Parkinson's disease
  • Able to understand, accept, and complete planned procedures
  • Parkinson's symptoms correspond to Hoehn & Yahr stage 1 or 2 in the medicated state
  • Mini Mental-State Examination score greater than 22
  • Able to understand, accept, and complete planned procedures (Healthy Reference Group)
Not Eligible

You will not qualify if you...

  • 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 anti-Parkinson medication within 6 weeks before starting T-PEMF treatment
  • Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep
  • Neurological diseases other than Parkinson's disease
  • Previous stroke
  • Reduced motor function caused by conditions other than Parkinson's disease
  • Neurological disease (Healthy Reference Group)
  • Reduced motor function caused by condition (Healthy Reference Group)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

2

University of Southern Denmark

Odense, Denmark, 5230

Actively Recruiting

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Research Team

A

Anne Sofie Bøgh Malling, Ph.d.

CONTACT

B

Bente Rona Jensen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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