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

March 4, 2020 updated by: Bo Mohr Morberg, Odense University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Funen
      • Odense C, Funen, Denmark, 5000
        • OUH Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • The devise name is: Re5 - Parkinson Treatment System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and at endpoint at week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-PEMF14
  • CIV-14-01-011780 (Other Identifier: Danish Health and Medicines Authority)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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