Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT02125032|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : March 5, 2020
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 .
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF) Device: Placebo Transcranial low voltage electromagnetic fields||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||March 2018|
Active Comparator: Transcranial pulsed electromagnetic fields (T-PEMF)
One group receives 8 weeks of active T-PEMF treatment and another group receives 8 weeks of placebo T-PEMF. Both treatments to be performed 30 minutes once a day.
Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)
Other Name: The device name is: Re5 - Parkinson Treatment System
Placebo Comparator: Trancranial electromagnetic pulsed fields (T-PEMF)
8 weeks of T-PEMF treatment placebo.
Device: Placebo Transcranial low voltage electromagnetic fields
Other Name: The devise name is: Re5 - Parkinson Treatment System
- Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125032
|OUH Odense University Hospital|
|Odense C, Funen, Denmark, 5000|