PARKINSON DISEASE (Disorder)
Conditions
Keywords
T-PEMF
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.
Interventions
DEVICETranscranial pulsed electromagnetic fields (T-PEMF)
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
DEVICESham (No Treatment)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Sponsors
University of Southern Denmark
Odense University Hospital
Bente & Erik Schøller Larsens Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Masking only applies to the intervention groups. The control group and reference group are Open Label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tremor intensity | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. | Postural tremor intensity assessed by accelerometer |
| Rate of force development | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. | Isometric rate of force development assessed by handgrip and knee extension |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. | 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). |
| Cerebrospinal fluid biomarkers | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only. | 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). |
Countries
Denmark
Contacts
CONTACTAnne Sofie Bøgh Malling, Ph.d.
CONTACTBente Rona Jensen, Professor
PRINCIPAL_INVESTIGATORAnne Sofie Bøgh Malling, Ph.d.
University of Southern Denmark
Outcome results
None listed