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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-03-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcranial low voltage pulsed electromagnetic fields (T-PEMF)

Intervention Type DEVICE

Trancranial electromagnetic pulsed fields (T-PEMF)

8 weeks of T-PEMF treatment placebo.

Group Type PLACEBO_COMPARATOR

Placebo Transcranial low voltage electromagnetic fields

Intervention Type DEVICE

Interventions

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Transcranial low voltage pulsed electromagnetic fields (T-PEMF)

Intervention Type DEVICE

Placebo Transcranial low voltage electromagnetic fields

Intervention Type DEVICE

Other Intervention Names

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The device name is: Re5 - Parkinson Treatment System The devise name is: Re5 - Parkinson Treatment System

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No