Parkinson Disease
Conditions
Brief summary
The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general. Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .
Interventions
DEVICETranscranial low voltage pulsed electromagnetic fields (T-PEMF)
DEVICEPlacebo Transcranial low voltage electromagnetic fields
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Idiopathic Parkinson's disease H & Y 1-3 (Hoehn&Yahr) * MMSE \> 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination) * Age \> 18 years. * The patient is capable understanding, accepting and complete the planned procedures.
Exclusion criteria
* The patient has been using T-PEMF before. * Changes in anti-parkinson drug treatment within the last 6 weeks * Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient * Psychosis, or other psychopathological conditions, which requires intervention * The abuse of alcohol or drugs * Treatment with Deep Brain stimulation. * Pregnancy or nursing * Epilepsy. * Active implants such as pacemakers and others for example cochlear implants * Active medical device for example insulin pumps, baclofen pumps. * Participation in other trials in the intervention period * Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer * Autoimmune disease * Wounds in the scalp
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS) | At baseline and at endpoint at week 8. | Comment on Title: It is expected that the outcome measure UPDRS will report a change after 8 weeks of treatment compared to baseline. Comment on Time Frame: Data will be assessed at each group after 8 weeks, and will be presented when all included patients have received their intervention. |
Countries
Denmark
Outcome results
None listed