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

Odense University Hospital

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Placebo Transcranial low voltage electromagnetic fields; Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02125032

CIV-14-01-011780 (Other Identifier)

T-PEMF14

Details and patient eligibility

About

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 .

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Transcranial pulsed electromagnetic fields (T-PEMF)

Active Comparator group

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.

Treatment:

Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)

Trancranial electromagnetic pulsed fields (T-PEMF)

Placebo Comparator group

Description:

8 weeks of T-PEMF treatment placebo.

Treatment:

Device: Placebo Transcranial low voltage electromagnetic fields