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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
Sponsor:
Information provided by (Responsible Party):
Bo Mohr Morberg, Odense University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
OUH Odense University Hospital
Odense C, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bo Mohr Morberg, MD, Ph.D. student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02125032    
Other Study ID Numbers: T-PEMF14
CIV-14-01-011780 ( Other Identifier: Danish Health and Medicines Authority )
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases