The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
NCT07306104 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-29
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.
Conditions
- PARKINSON DISEASE (Disorder)
Interventions
- DEVICE
-
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
- DEVICE
-
Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Sponsors & Collaborators
-
Odense University Hospital
collaborator OTHER -
Bente & Erik Schøller Larsens Foundation
collaborator UNKNOWN -
University of Southern Denmark
lead OTHER
Principal Investigators
-
Anne Sofie Bøgh Malling, Ph.d. · University of Southern Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-16
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
Countries
- Denmark
Study Locations
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