Clinical trial Recruiting at 1 site Interventional Ages 18 and up

TMS markers to detect and predict thinking problems in Parkinson's disease

Official title: Transcranial Magnetic Stimulation (TMS) Related Measures as Biomarker of Cognitive Impairment in Parkinson's Disease (PD)

Run by Azienda Sanitaria Universitaria Integrata del Trentino · NCT06835595 · Data updated 2026-11-12

This project will test whether paired-pulse TMS brain measurements can distinguish and predict cognitive decline in people with Parkinson's disease.

More Parkinson Disease trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment52 (estimated)
SponsorAzienda Sanitaria Universitaria Integrata del Trentino
Academic / other
Drugs / interventionschemotherapy
Locations3 sites (Trieste, Friuli Venezia Giulia and 2 other locations)
StatusRecruiting
StartedSeptember 10, 2025
Main results expectedJanuary 1, 2029
Study endsJanuary 1, 2029
Registry record updatedDecember 22, 2025
Trial IDNCT06835595 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with idiopathic Parkinson's disease who can complete extensive neuropsychological testing, provide informed consent, and have been on stable antiparkinsonian medication for at least four weeks are ideal candidates.

Probably not a fit

People with other active neurological diseases, cochlear or ferromagnetic implants, pacemakers or other implantable stimulators, a history of epilepsy, pregnancy or breastfeeding, or severe systemic illness would be excluded and not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use paired-pulse transcranial magnetic stimulation (TMS) techniques — including SICI, SAI, and ICF — to measure cortical excitability and specific neurotransmission-related circuits in people with Parkinson's disease. Participants will undergo detailed neuropsychological testing to classify them as cognitively normal, PD with mild cognitive impairment (PD-MCI), or PD with dementia (PD-D), and TMS measures will be compared across these groups. The study will also track whether baseline TMS markers predict later cognitive decline. Standard exclusions apply, such as implanted ferromagnetic or electronic devices and a history of epilepsy.

Why it matters

Potential benefit: If successful, these TMS measures could provide a noninvasive biomarker to detect early cognitive decline in Parkinson's and help guide monitoring or treatment decisions.

How similar studies have gone: Paired-pulse TMS approaches have shown promise in Alzheimer's and related dementias and in small Parkinson's studies, but they are not yet established as routine clinical biomarkers.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • UOC Neurologia - Azienda Provinciale per i Servizi Sanitari (APSS)
    Trento, Trentino-Alto Adige, Italy
    Recruiting
  • SC Clinica Neurologica - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
    Trieste, Friuli Venezia Giulia, Italy
    Not yet recruiting
  • UOC Neuroriabilitazione - Azienda Sanitaria dell'Alto Adige
    Sterzing, Trentino-Alto Adige, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Ruggero Bacchin, MD — UOC Neurologia - Azienda Sanitaria per i Servizi Sanitari (APSS)
  • Study coordinator: Ruggero Bacchin, MD
  • Email: ruggero.bacchin@apss.tn.it
  • Phone: +39-0461903281

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.