search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcranial low voltage pulsed electromagnetic fields (T-PEMF)
Placebo Transcranial low voltage electromagnetic fields
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OUH Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transcranial pulsed electromagnetic fields (T-PEMF)

Trancranial electromagnetic pulsed fields (T-PEMF)

Arm Description

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.

8 weeks of T-PEMF treatment placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2014
Last Updated
March 4, 2020
Sponsor
Odense University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02125032
Brief Title
Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial pulsed electromagnetic fields (T-PEMF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trancranial electromagnetic pulsed fields (T-PEMF)
Arm Type
Placebo Comparator
Arm Description
8 weeks of T-PEMF treatment placebo.
Intervention Type
Device
Intervention Name(s)
Transcranial low voltage pulsed electromagnetic fields (T-PEMF)
Other Intervention Name(s)
The device name is: Re5 - Parkinson Treatment System
Intervention Type
Device
Intervention Name(s)
Placebo Transcranial low voltage electromagnetic fields
Other Intervention Name(s)
The devise name is: Re5 - Parkinson Treatment System
Primary Outcome Measure Information:
Title
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
OUH Odense University Hospital
City
Odense C
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30704504
Citation
Malling ASB, Morberg BM, Wermuth L, Gredal O, Bech P, Jensen BR. The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease. J Neuroeng Rehabil. 2019 Jan 31;16(1):19. doi: 10.1186/s12984-019-0491-2.
Results Reference
derived
PubMed Identifier
29573167
Citation
Morberg BM, Malling AS, Jensen BR, Gredal O, Bech P, Wermuth L. Effects of transcranial pulsed electromagnetic field stimulation on quality of life in Parkinson's disease. Eur J Neurol. 2018 Jul;25(7):963-e74. doi: 10.1111/ene.13637. Epub 2018 Apr 17.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs