The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: PARKINSON DISEASE (Disorder)

Treatments: Device: Sham (No Treatment); Device: Transcranial pulsed electromagnetic fields (T-PEMF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07306104

SDURio #12.562

2501906 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are:

• How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease?
• How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake?

The neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake.

Participants in the intervention group will:

• receive one 30 min treatment session daily for 12 months
• receive either T-PEMF or sham treatment for the first 6 months
• receive active T-PEMF treatment the last 6 months
• visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Intervention Groups

Inclusion Criteria:

• Diagnosed with idiopathic Parkinson's disease
• The participant must be able to understand, accept, and complete the planned procedures
• Parkinson's symptoms in the medicated state must correspond to Hoehn & Yahr stage 1 or 2
• Mini Mental-State Examination score > 22

Exclusion Criteria:

• Cancer in the brain, neck, or head area
• Presence of active medical implants
• Epilepsy
• Alcoholism
• Substance abuse
• Open wound on the scalp
• Severe psychopathological disorders
• Pregnancy
• Changes in pharmacological anti-Parkinson medication within the last 6 weeks prior to the start of T-PEMF treatment
• Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep
• Neurological disease other than Parkinson's disease
• Previous stroke
• Reduced motor function caused by conditions other than Parkinson's disease

Control Group with Parkinson's Disease

Inclusion Criteria:

• Diagnosed with idiopathic Parkinson's disease
• The patient must be able to understand, accept, and complete the planned procedures
• Parkinson's symptoms in the medicated state must correspond to Hoehn & Yahr stage 1 or 2
• Mini Mental-State Examination score > 22

Exclusion Criteria:

• Neurological disease other than Parkinson's disease
• Reduced motor function caused by conditions other than Parkinson's disease

Healthy Reference Group:

Inclusion Criteria:

-The patient must be able to understand, accept, and complete the planned procedures

Exclusion Criteria:

• Neurological disease
• Reduced motor function caused by condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 4 patient groups

Intervention group 1: Full T-PEMF

Experimental group

Description:

Persons with Parkinson's disease receiving 30 min daily active T-PEMF for 12 months. The first 6 months are blinded, the last 6 months are not.

Treatment:

Device: Transcranial pulsed electromagnetic fields (T-PEMF)

Intervention group 2: sham + T-PEMF

Sham Comparator group

Description:

Persons with Parkinson's disease receiving 30 min daily sham T-PEMF for 6 months followed by 6 moths of 30 min daily active T-PEMF. The first 6 month is blinded, the last 6 months are not.

Treatment:

Device: Transcranial pulsed electromagnetic fields (T-PEMF)

Device: Sham (No Treatment)

Control group

No Intervention group

Description:

Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.

Healthy reference group

No Intervention group

Description:

Health age-matched persons assessed once to obtain age-matched normal intervals of performance.