PARKINSON DISEASE (Disorder)NCT07306104
The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
A study testing Transcranial pulsed electromagnetic fields (T-PEMF) in people with PARKINSON DISEASE (Disorder), run by University of Southern Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Transcranial pulsed electromagnetic fields (T-PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Diagnosed with idiopathic Parkinson's disease
- The patient must be able to understand, accept, and complete the planned procedures
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- 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
Who cannot join
- Cancer in the brain, neck, or head area
- Presence of active medical implants
- Epilepsy
- Alcoholism
- Substance abuse
- Open wound on the scalp
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bente Rona Jensen, Professor contact
Denmark2 sites, 2 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Christian Winterberg, MD, +45 65411833, christian.winterberg@rsyd.dk
Christian Winterberg, MD
- Recruiting
University of Southern Denmark
Odense, 5230
Anne Sofie Bøgh Malling, Ph.d., +45 28903733, amalling@health.sdu.dk
Jens Bojsen-Møller, Ass. proffessor, jbojsen@health.sdu.dk
About this study
Official title: The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
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?
Read more
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Transcranial pulsed electromagnetic fields (T-PEMF), Sham (No Treatment)
- Keywords
- T-PEMF
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1: Full T-PEMF | Experimental | 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. Receives: Device: Transcranial pulsed electromagnetic fields (T-PEMF) |
| Intervention group 2: sham + T-PEMF | Sham comparator | 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. Receives: Device: Transcranial pulsed electromagnetic fields (T-PEMF); Device: Sham (No Treatment) |
| Control group | No intervention | Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease. |
| Healthy reference group | No intervention | Health age-matched persons assessed once to obtain age-matched normal intervals of performance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-stand
Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.
Measured: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Secondary outcomes (4)
Tremor intensity
Postural tremor intensity assessed by accelerometer
Measured: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Rate of force development
Isometric rate of force development assessed by handgrip and knee extension
Measured: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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).
Measured: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Cerebrospinal fluid biomarkers
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).
Measured: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start16 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Bente & Erik Schøller Larsens Foundation
- Responsible party
- Sponsor
- Investigators
- Anne Sofie Bøgh Malling, Ph.d., Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306104
- Sponsor's protocol ID
- SDURio #12.562
- Other IDs
- 2501906
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
- ClinicalTrials.gov ID
- NCT07306104
- Acronym / sponsor ID
- SDURio #12.562
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- T-PEMF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Bente & Erik Schøller Larsens Foundation
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1: Full T-PEMF | Experimental | Device: Transcranial pulsed electromagnetic fields (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. |
| Intervention group 2: sham + T-PEMF | Sham comparator | Device: Transcranial pulsed electromagnetic fields (T-PEMF), Device: Sham (No Treatment)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. |
| Control group | No intervention | –Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease. |
| Healthy reference group | No intervention | –Health age-matched persons assessed once to obtain age-matched normal intervals of performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Diagnosed with idiopathic Parkinson's disease
Key exclusion criteria (19 listed)
- Cancer in the brain, neck, or head area
- Presence of active medical implants
- Epilepsy
- Alcoholism
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial pulsed electromagnetic fields (T-PEMF)30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz) | Device | Intervention group 1: Full T-PEMF, Intervention group 2: sham + T-PEMF |
| Sham (No Treatment)30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs | Device | Intervention group 2: sham + T-PEMF |
Primary outcome
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.
4 secondary outcomes
Tremor intensity
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Rate of force development
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bente Rona Jensen, Professor contact
Anne Sofie Bøgh Malling, Ph.d. principal investigator
University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial pulsed electromagnetic fields (T-PEMF) in people with PARKINSON DISEASE (Disorder), run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Sofie Bøgh Malling, Ph.d. (+45 28903733, amalling@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit-to-stand (time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.