Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07306104

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

PARKINSON DISEASE (Disorder) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial pulsed electromagnetic fields (T-PEMF)

Device

30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)

Sham (No Treatment)

Device

30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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).

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Sofie Bøgh Malling, Ph.d.

CONTACT

[email protected]

+45 28903733

Bente Rona Jensen, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Bente & Erik Schøller Larsens Foundation
  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.