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

April 28, 2026 updated by: University of Southern Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
        • Principal Investigator:
          • Christian Winterberg, MD
      • Odense, Denmark, 5230
        • Recruiting
        • University of Southern Denmark
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne Sofie B Malling, Ph.d.
        • Sub-Investigator:
          • Mikkel C Juhl, MSc
        • Sub-Investigator:
          • Morten Meyer, Professor
        • Sub-Investigator:
          • Bente R Jensen, Professor
        • Sub-Investigator:
          • Jens Bojsen-Møller, Ass. Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Intervention Groups

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Neurological disease other than Parkinson's disease
  • Reduced motor function caused by conditions other than Parkinson's disease

Healthy Reference Group:

Inclusion Criteria:

-The patient must be able to understand, accept, and complete the planned procedures

Exclusion Criteria:

  • Neurological disease
  • Reduced motor function caused by condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham Comparator: 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.
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
No Intervention: Control group
Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
No Intervention: Healthy reference group
Health age-matched persons assessed once to obtain age-matched normal intervals of performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sit-to-stand
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor intensity
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Postural tremor intensity assessed by accelerometer
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Rate of force development
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Isometric rate of force development assessed by handgrip and knee extension
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)
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
The MDS-UPDRS will be reported as total score (0-260, higher scores indicate greater disease severity) and motor score (part III, 0-132, higher scores indicate greater disease severity).
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Cerebrospinal fluid biomarkers
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.
Concentration of growth factors, cytokines and cytoskeletal proteins with special emphasis on erythropoietin (EPO), vascular endothelial growth factor (VEGF), brain-derived neutrophic factor (BDNF), glia cell derived neutrophilic factor (GDNF), Glucagon Like Peptide 1 (GLP1), interleukins and neurofilament light chain (NfL).
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMG
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Electromyographic recordings of forearm and thigh muscles during motor assessments (sit-to-stand, isometric contractions, postural tremor assessment, handwriting). Applied for explorative analyses, thus exact outcomes are not yet specified. However, agonist drive and co-contraction ratio may be assessed.
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Hand writing
Time Frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Hand writing test performed with ink pen on paper on top of tablet (digitalizing handwriting). Performed as an explorative assessment.
From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Bente & Erik Schøller Larsens Foundation

Investigators

  • Principal Investigator: Anne Sofie Bøgh Malling, Ph.d., University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDURio #12.562
  • 2501906 (Other Identifier: The Danish Medical Research Ethics Committees)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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