The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial pulsed electromagnetic fields (T-PEMF), Sham (No Treatment).
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
Overview
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.
Interventions
- Device Transcranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz) - Device Sham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Primary outcome measures
- Sit-to-stand [Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.]
Secondary outcome measures (4)
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Odense University Hospital — Odense
- University of Southern Denmark — Odense
Identifiers
NCT: NCT07306104 · SDURio #12.562 · 2501906