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

NCT07306104 · University of Southern Denmark

Recruiting

In plain English

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Official title

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

About this study

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.

Eligibility criteria

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 design

Enrollment target: 90 participants

Allocation: randomized

Masking: triple

Age groups: adult, older_adult

Timeline

Starts: 2026-02-01

Estimated completion: 2028-01

Last updated: 2025-12-29

Interventions

Device: Transcranial pulsed electromagnetic fields (T-PEMF)Device: Sham (No Treatment)

Primary outcomes

• Sit-to-stand (From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.)

Sponsor

University of Southern Denmark · other

With: Odense University Hospital, Bente & Erik Schøller Larsens Foundation

Contacts & investigators

ContactAnne Sofie Bøgh Malling, Ph.d. · contact · amalling@health.sdu.dk · +45 28903733

ContactBente Rona Jensen, Professor · contact · brjensen@health.sdu.dk

InvestigatorAnne Sofie Bøgh Malling, Ph.d. · principal_investigator, University of Southern Denmark

All locations (2)

Odense University HospitalRecruiting

Odense, Denmark

University of Southern DenmarkRecruiting

Odense, Denmark

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