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The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

⁃ 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

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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
University of Southern Denmark
RECRUITING
Odense
Contact Information
Primary
Anne Sofie Bøgh Malling, Ph.d.
amalling@health.sdu.dk
+45 28903733
Backup
Bente Rona Jensen, Professor
brjensen@health.sdu.dk
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 90
Treatments
Experimental: Intervention group 1: Full T-PEMF
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.
Sham_comparator: Intervention group 2: sham + T-PEMF
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.
No_intervention: Control group
Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
No_intervention: Healthy reference group
Health age-matched persons assessed once to obtain age-matched normal intervals of performance.
Related Therapeutic Areas
Sponsors
Collaborators: Bente & Erik Schøller Larsens Foundation, Odense University Hospital
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov