NCT07306104 The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
| NCT ID | NCT07306104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern Denmark |
| Condition | PARKINSON DISEASE (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-02-16 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Anne Sofie Bøgh Malling, Ph.d.
PRINCIPAL INVESTIGATOR
University of Southern Denmark
Frequently Asked Questions
Who can join the NCT07306104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PARKINSON DISEASE (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07306104 currently recruiting?
Yes, NCT07306104 is actively recruiting participants. Contact the research team at amalling@health.sdu.dk for enrollment information.
Where is the NCT07306104 trial being conducted?
This trial is being conducted at Odense, Denmark, Odense, Denmark.
Who is sponsoring the NCT07306104 clinical trial?
NCT07306104 is sponsored by University of Southern Denmark. The principal investigator is Anne Sofie Bøgh Malling, Ph.d. at University of Southern Denmark. The trial plans to enroll 90 participants.
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