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
2 other identifiers
interventional
90
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 29, 2025
CompletedStudy Start
First participant enrolled
February 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 29, 2026
April 1, 2026
1.9 years
November 21, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sit-to-stand
Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Secondary Outcomes (4)
Tremor intensity
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Rate of force development
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Cerebrospinal fluid biomarkers
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.
Other Outcomes (2)
EMG
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Hand writing
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Study Arms (4)
Intervention group 1: Full T-PEMF
EXPERIMENTALPersons 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.
Intervention group 2: sham + T-PEMF
SHAM COMPARATORPersons 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.
Control group
NO INTERVENTIONPersons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
Healthy reference group
NO INTERVENTIONHealth age-matched persons assessed once to obtain age-matched normal intervals of performance.
Interventions
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Diagnosed with idiopathic Parkinson's disease
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Odense University Hospitalcollaborator
- Bente & Erik Schøller Larsens Foundationcollaborator
Study Sites (2)
Odense University Hospital
Odense, 5000, Denmark
University of Southern Denmark
Odense, 5230, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Sofie Bøgh Malling, Ph.d.
University of Southern Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking only applies to the intervention groups. The control group and reference group are Open Label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 29, 2025
Study Start
February 16, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share