RecruitingNot ApplicableNCT06835595

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)


Sponsor

Azienda Sanitaria Universitaria Integrata del Trentino

Enrollment

52 participants

Start Date

Sep 10, 2025

Study Type

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

Min Age: 18 Years

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

DIAGNOSTIC_TESTTranscranial Magnetic Stimulation

Paired stimulation protocols of TMS to collect SAI, SICI, ICF measures


Locations(3)

SC Clinica Neurologica - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

Trieste, Friuli Venezia Giulia, Italy

UOC Neuroriabilitazione - Azienda Sanitaria dell'Alto Adige

Sterzing, Trentino-Alto Adige, Italy

UOC Neurologia - Azienda Provinciale per i Servizi Sanitari (APSS)

Trento, Trentino-Alto Adige, Italy

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NCT06835595


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