NCT06835595 TMS-related Measures as Biomarker of Cognitive Impairment in PD
| NCT ID | NCT06835595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria Universitaria Integrata del Trentino |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-09-10 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Luigi Cattaneo, MD, PhD
STUDY DIRECTOR
CIMEC - Centro Interdipartimentale Mente Cervello - Università degli studi di Trento
Frequently Asked Questions
Who can join the NCT06835595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835595 currently recruiting?
Yes, NCT06835595 is actively recruiting participants. Contact the research team at ruggero.bacchin@apss.tn.it for enrollment information.
Where is the NCT06835595 trial being conducted?
This trial is being conducted at Trieste, Italy, Sterzing, Italy, Trento, Italy.
Who is sponsoring the NCT06835595 clinical trial?
NCT06835595 is sponsored by Azienda Sanitaria Universitaria Integrata del Trentino. The principal investigator is Luigi Cattaneo, MD, PhD at CIMEC - Centro Interdipartimentale Mente Cervello - Università degli studi di Trento. The trial plans to enroll 52 participants.
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