Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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 .

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)
* Device: Placebo Transcranial low voltage electromagnetic fields


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcranial pulsed electromagnetic fields (T-PEMF)<br>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)<br> <br> * Other names: The device name is: Re5 - Parkinson Treatment System;|
| Placebo Comparator: Trancranial electromagnetic pulsed fields (T-PEMF)<br>8 weeks of T-PEMF treatment placebo. | Device: Placebo Transcranial low voltage electromagnetic fields<br> <br> * Other names: The devise name is: Re5 - Parkinson Treatment System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS) | 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. | At baseline and at endpoint at week 8. |