- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125032
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 .
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Funen
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Odense C, Funen, Denmark, 5000
- OUH Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Other Names:
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Placebo Comparator: Trancranial electromagnetic pulsed fields (T-PEMF)
8 weeks of T-PEMF treatment placebo.
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Other Names:
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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.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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