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

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 .

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OUH Odense University Hospital

Odense C, Funen, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial low voltage pulsed electromagnetic fields (T-PEMF)

Device

Other names: The device name is: Re5 - Parkinson Treatment System

Placebo Transcranial low voltage electromagnetic fields

Device

Other names: The devise name is: Re5 - Parkinson Treatment System

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: Apr 29, 2014
Registry last updated: Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed