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

Parkinson Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125032
• Other study ID #: T-PEMF14
• Secondary ID: CIV-14-01-011780
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

• Placebo Transcranial low voltage electromagnetic fields

Locations

Country	Name	City	State
Denmark	OUH Odense University Hospital	Odense C	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and at endpoint at week 8.