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NCT06804642Toboroz

Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

Rehabilitation of Locomotor Function in Parkinson's Disease by Non-invasive Spinal Cord Stimulation

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 11.

Rövid összefoglaló (regiszter, angolul)

This study explores the use of multifunctional, non-invasive spinal cord transcutaneous stimulation (scTS) to address axial motor symptoms, particularly gait dysfunction, in Parkinson's disease (PD). These symptoms, resistant to levodopa and inadequately managed by deep brain stimulation (DBS), arise from maladaptive spinal network changes. A non-invasive approach like scTS could overcome limitations associated with invasive spinal cord stimulation (SCS), which requires surgical implantation and lacks adaptability in stimulation site adjustments. Gait dysfunction in PD stems from disrupted interactions between spinal and supraspinal networks. scTS provides a non-invasive alternative, shown to enhance locomotor functions in conditions such as spinal cord injury, stroke, and cerebral palsy. This study hypothesizes that scTS applied at multiple spinal levels-cervical (C3-C4), thoracic (T11-T12), and lumbar (L1, L2-L3)-can synergistically activate locomotor central pattern generators (CPGs) and improve gait and postural control in PD. Additionally, it is hypothesized that proprioceptive input, combined with scTS, can counteract disruptions in spinal networks and restore voluntary movement. The primary goal is to evaluate the effects of scTS on stepping performance, postural control, and locomotor recovery in PD. Specific objectives include: 1. Enhancing Locomotor Networks * Determine optimal scTS parameters for inducing rhythmic stepping in PD patients. * Assess interactions between spinal and supraspinal networks during imagined stepping under scTS in a gravity-neutral setting. 2. Improving Postural Networks o Evaluate the effectiveness of scTS in restoring postural control and integrating postural-locomotor functions. 3. Facilitating Neuroplasticity for Movement Recovery o Combine scTS with activity-based recovery training to promote adaptive plasticity in spinal and cortical networks, reducing freezing of gait (FOG). The research will measure scTS's capacity to generate coordinated stepping and postural movements, integrate proprioceptive feedback, and induce long-term improvements in gait parameters. By targeting spinal locomotor and postural systems, scTS offers a novel, non-invasive approach to addressing gaps in the management of PD gait dysfunction. This work has the potential to significantly enhance the quality of life for individuals with PD, providing a safe, adaptable, and patient-centered therapeutic solution.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
20 (tervezett)
Első benyújtás
2024. dec. 18.
Kezdés
2024. dec. 12.
Elsődleges befejezés
2029. dec. 11.
Fő szponzor
University of Louisville
Betegségek
Parkinson-kór
NCT-szám
NCT06804642

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 20
  • 2024. dec. 12. és az elsődleges befejezés (2029. dec. 11.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Clinically significant depression or major active psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder;
  • Terminal illness associated with \<12-month survival;
  • Have a current diagnosis or condition such as major cardiac insufficiency, determined clinically by the study doctors;
  • Individuals with any illness that, in the study doctors' opinion, may preclude them from spinal cord transcutaneous stimulation, activity-based recovery training, or participation in study assessments.

Egyéb

  • Co-morbidities affecting gait;
  • Clinically significant cognitive dysfunction;
  • Current alcohol or substance abuse that is uncontrolled or unmanageable;
  • Individuals unable to communicate with the investigator and study staff; and/or

Kiket keres a vizsgálat

  • Diagnosis of Parkinson's disease;
  • Adults aged 18 to 80 years;
  • Competent to give informed consent for the research protocol;
  • Able to understand instructions;
  • Able to ambulate 10-meters.

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Frazier Rehab Institute
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LouisvilleEgyesült ÁllamokToboroz

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