The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
NCT ID: NCT07306104
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2026-02-01
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
NCT02125032
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
NCT00287703
Study of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease
NCT00029666
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
NCT01353092
Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
NCT03350464
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
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.
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Control group
Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
No interventions assigned to this group
Healthy reference group
Health age-matched persons assessed once to obtain age-matched normal intervals of performance.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
-The patient must be able to understand, accept, and complete the planned procedures
Exclusion Criteria
* 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
* Neurological disease other than Parkinson's disease
* Reduced motor function caused by conditions other than Parkinson's disease
Healthy Reference Group:
* Neurological disease
* Reduced motor function caused by condition
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Bente & Erik Schøller Larsens Foundation
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Sofie Bøgh Malling, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Odense University Hospital
Odense, , Denmark
University of Southern Denmark
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2501906
Identifier Type: OTHER
Identifier Source: secondary_id
SDURio #12.562
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.