TMS-related Measures as Biomarker of Cognitive Impairment in PD
Transcranial Magnetic Stimulation (TMS) Related Measures as Biomarker of Cognitive Impairment in Parkinson's Disease (PD)
Azienda Sanitaria Universitaria Integrata del Trentino
52 participants
Sep 10, 2025
INTERVENTIONAL
Conditions
Summary
The goal of the present study is to explore the diagnostic and prognostic value of neurophysiological biomarkers obtained through paired-pulse Transcranial Magnetic Stimulation (TMS) techniques in individuals affected by Parkinson's disease (PD) with and without cognitive decline. The main questions it aims to answer are: * TMS measures of cortical excitability are able to distinguish between PD patients cognitively normal, PD-Mild Cognitive Impairment (PD-MCI) and PD-Dementia (PD-D)? * TMS measures of cortical excitability are able to predict progression of PD patient cognitive status from cognitively normal to PD-MCI and PD-D?
Eligibility
Inclusion Criteria5
- Age \> 18 years
- Ability to undergo an extensive neuropsychological evaluation
- Ability to sign informed consent for the study
- Diagnosed with idiopathic PD according to the latest revision of the MDS criteria
- On stable and optimal antiparkinsonian therapy for at least four weeks
Exclusion Criteria11
- Systemic diseases of significant severity, including cardiovascular and cerebrovascular conditions (e.g., active neoplasms requiring chemotherapy, or end-stage heart failure)
- Presence of any active neurological disease, in addition to PD
- Presence of a cochlear implant, ferromagnetic brain device or near the site of brain stimulation, pacemaker, brain electrodes for DBS, electromechanical devices with IPG, or any other implantable stimulator, including peripheral ones
- History of epilepsy
- History of cerebrovascular, tumor-related, infectious, or metabolic brain conditions predisposing to seizures or causing symptomatic epilepsy
- Pregnancy or breastfeeding
- Alcoholism
- Treatment with anticholinesterase drugs, benzodiazepines, neuroleptics, anticholinergics, or antidepressants in the last month
- Treatment with drugs that lower the seizure threshold (e.g., imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, MDMA, ecstasy, phencyclidine, ketamine, gamma-hydroxybutyrate, alcohol, theophylline)
- Active cochlear pathology (especially if currently receiving ototoxic drugs, such as aminoglycoside antibiotics)
- Dementia according to the latest revision of the MDS criteria for PDD
Interventions
Paired stimulation protocols of TMS to collect SAI, SICI, ICF measures
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06835595