The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
NCT ID: NCT07306104
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2026-02-01
2028-01-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention group 1: Full T-PEMF
Persons with Parkinson's disease receiving 30 min daily active T-PEMF for 12 months. The first 6 months are blinded, the last 6 months are not.
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Intervention group 2: sham + T-PEMF
Persons with Parkinson's disease receiving 30 min daily sham T-PEMF for 6 months followed by 6 moths of 30 min daily active T-PEMF. The first 6 month is blinded, the last 6 months are not.
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Control group
Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
No interventions assigned to this group
Healthy reference group
Health age-matched persons assessed once to obtain age-matched normal intervals of performance.
No interventions assigned to this group
Interventions
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Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Odense University Hospital
OTHER
Bente & Erik Schøller Larsens Foundation
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Anne Sofie Bøgh Malling, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Odense University Hospital
Odense, , Denmark
University of Southern Denmark
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Christian Winterberg, MD
Role: primary
Anne Sofie Bøgh Malling, Ph.d.
Role: primary
Jens Bojsen-Møller, Ass. proffessor
Role: backup
Other Identifiers
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2501906
Identifier Type: OTHER
Identifier Source: secondary_id
SDURio #12.562
Identifier Type: -
Identifier Source: org_study_id