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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF); Device: Placebo Transcranial low voltage electromagnetic fields

• Registration Number: NCT02125032
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-29
• Study Start: 2014-05
• Primary Completion: 2017-10
• Study Completion: 2018-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial pulsed electromagnetic fields (T-PEMF)	Transcranial low voltage 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.
Trancranial electromagnetic pulsed fields (T-PEMF)	Placebo Transcranial low voltage electromagnetic fields	8 weeks of T-PEMF treatment placebo.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)	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.

Trial Locations

Locations (1)

OUH Odense University Hospital; 🇩🇰 Odense C, Funen, Denmark