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

Odense University Hospital98 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

Transcranial low voltage pulsed electromagnetic fields (T-PEMF)DEVICE

Placebo Transcranial low voltage electromagnetic fieldsDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

OUH Odense University Hospital

Odense C, Funen, Denmark

Outcomes

Primary Outcomes

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.

Time frame: At baseline and at endpoint at week 8.

Data from ClinicalTrials.gov

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