TMS markers to detect and predict thinking problems in Parkinson's disease
Transcranial Magnetic Stimulation (TMS) Related Measures as Biomarker of Cognitive Impairment in Parkinson's Disease (PD)
This project will test whether paired-pulse TMS brain measurements can distinguish and predict cognitive decline in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria Universitaria Integrata del Trentino Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Trieste, Friuli Venezia Giulia and 2 other locations) |
| Trial ID | NCT06835595 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Trieste, Friuli Venezia Giulia and 2 other locations
- 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)
- UOC Neurologia - Azienda Provinciale per i Servizi Sanitari (APSS) — Trento, Trentino-Alto Adige, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.