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Biomarkers of Neurodegeneration and Neuroplasticity in Parkinson's Disease Patients Treated by Bilateral M1-iTBS

NCT06840145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-21

No results posted yet for this study

Summary

Intermittent theta-burst stimulation (iTBS) is a promising therapeutic option for Parkinson's disease patients. A study involving 24 patients will assess its effectiveness in alleviating clinical deficits. Patients will undergo 5 sessions of iTBS over the bilateral M1 and a 3-month washout period. Motor evaluation, neurocognitive assessment, serum biomarkers of neurodegeneration and neuroplasticity, and structural and functional MRI evaluations will be conducted at follow-up visits.

Conditions

Interventions

DEVICE

repetitive transcranial magnetic stimulation

Intermittent theta Burst stimulation will be performed as detailed in the Real arm description

Sponsors & Collaborators

  • Ministry of Science and Innovation, Spain

    collaborator OTHER_GOV

  • Andalusian Ministry of Health and Families

    collaborator UNKNOWN

  • Andalusian Ministry of University, Research and Innovation

    collaborator UNKNOWN

  • University of Cadiz

    collaborator OTHER

  • Hospital Universitario Puerta del Mar

    collaborator OTHER

  • Instituto de investigación e innovación biomédica de Cádiz

    lead OTHER

Principal Investigators

  • Javier J. Gonzalez-Rosa, PhD · University of Cadiz & Institute of Biomedical Research Cadiz (INiBICA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-02-12
Completion
2024-04-12

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840145 on ClinicalTrials.gov