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Идёт набор NCT07306104

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

Без фазы С лечением PARKINSON DISEASE (Disorder)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial pulsed electromagnetic fields (T-PEMF), Sham (No Treatment).
Кому может быть актуально
Состояния в реестре: PARKINSON DISEASE (Disorder). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство Transcranial pulsed electromagnetic fields (T-PEMF)
    30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
  • Устройство Sham (No Treatment)
    30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs

Первичные конечные точки

  • Sit-to-stand [Срок оценки: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.]
Вторичные конечные точки (4)
  • Tremor intensity [Срок оценки: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.]
  • Rate of force development [Срок оценки: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.]
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Срок оценки: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.]
  • Cerebrospinal fluid biomarkers [Срок оценки: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.]

Критерии участия

Intervention Groups

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии включения

  • 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

Критерии исключения

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

Healthy Reference Group:

Критерии включения

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

Критерии исключения

  • Neurological disease
  • Reduced motor function caused by condition

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Дания · 2 центра
  • Odense University Hospital — Odense
  • University of Southern Denmark — Odense

Идентификаторы

NCT: NCT07306104 · SDURio #12.562 · 2501906

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗