Daily transcranial pulsed electromagnetic field (T-PEMF) therapy for Parkinson's disease
The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
This trial tests whether daily 30-minute sessions of transcranial pulsed electromagnetic fields (T-PEMF) help people with early-stage Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 2 sites (Odense and 1 other locations) |
| Trial ID | NCT07306104 on ClinicalTrials.gov |
What this trial studies
Researchers will compare daily 30-minute T-PEMF treatment against a sham (placebo) over 6 and 12 months to measure effects on neuro-mechanical and molecular biological markers and on medication needs. Outcomes in participants will be compared with the disorder's natural progression and with a healthy reference group. Eligible participants are people with idiopathic Parkinson's disease in Hoehn & Yahr stage 1–2 with preserved cognition (MMSE > 22) and without contraindications such as active implants, epilepsy, or anticoagulant use. The protocol includes careful monitoring of motor function and biological measures, with the goal of tracking changes over time versus placebo.
Who should consider this trial
Good fit: Ideal candidates are people with early-stage idiopathic Parkinson's disease (Hoehn & Yahr 1–2), MMSE > 22, who can follow daily 30-minute treatment routines and have no active head/brain implants or other exclusionary conditions.
Not a fit: People with advanced Parkinson's, major cognitive impairment, active brain/neck implants, epilepsy, recent changes in Parkinson medications, anticoagulant therapy, or other neurological disorders are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, daily T-PEMF could improve motor function and potentially reduce the amount of Parkinson's medication needed.
How similar studies have performed: Some small clinical and preclinical studies of T-PEMF or related pulsed electromagnetic therapies have reported preliminary symptomatic or biomarker changes, but large randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Odense and 1 other locations
- Odense University Hospital — Odense, Denmark (Recruiting)
- University of Southern Denmark — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Anne Sofie Bøgh Malling, Ph.d. — University of Southern Denmark
- Study coordinator: Anne Sofie Bøgh Malling, Ph.d.
- Email: amalling@health.sdu.dk
- Phone: +45 28903733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.