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| ID | Type | Description | Link |
|---|---|---|---|
| 2501906 | Other Identifier | The Danish Medical Research Ethics Committees |
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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Bente & Erik Schøller Larsens Foundation | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial pulsed electromagnetic fields (T-PEMF) | Device | 30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand | Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate. | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor intensity | Postural tremor intensity assessed by accelerometer | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. |
| Rate of force development |
| Measure | Description | Time Frame |
|---|---|---|
| EMG | Electromyographic recordings of forearm and thigh muscles during motor assessments (sit-to-stand, isometric contractions, postural tremor assessment, handwriting). Applied for explorative analyses, thus exact outcomes are not yet specified. However, agonist drive and co-contraction ratio may be assessed. | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. |
Intervention Groups
Inclusion Criteria:
Exclusion Criteria:
Control Group with Parkinson's Disease
Inclusion Criteria:
Exclusion Criteria:
Healthy Reference Group:
Inclusion Criteria:
-The patient must be able to understand, accept, and complete the planned procedures
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Sofie Bøgh Malling, Ph.d. | Contact | +45 28903733 | amalling@health.sdu.dk | |
| Bente Rona Jensen, Professor | Contact | brjensen@health.sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anne Sofie Bøgh Malling, Ph.d. | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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Masking only applies to the intervention groups. The control group and reference group are Open Label.
| Sham (No Treatment) | Device | 30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs |
|
Isometric rate of force development assessed by handgrip and knee extension
| 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). | 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). | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only. |
| Hand writing | Hand writing test performed with ink pen on paper on top of tablet (digitalizing handwriting). Performed as an explorative assessment. | From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. |
| University of Southern Denmark | Recruiting | Odense | 5230 | Denmark |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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