TMS-related Measures as Biomarker of Cognitive Impairment in PD
Recruiting · NCT06835595 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Sanitaria Universitaria Integrata del Trentino
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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?
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
3 locations listed.
- 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