TMS-related Measures as Biomarker of Cognitive Impairment in PD

NCT06835595 | Recruiting

• 2 other identifiers: A969SAIPD22
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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?

Conditions

Parkinson Disease

Keywords

Parkinson's; Neurologic Manifestations; Parkinson Disease; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Brain Diseases; Neurotransmitter Agents; Transcranial Magnetic Stimulation; Sensory Motor Integration; Cortical Excitability

Outcome Measures

Primary Outcomes (2)

• To compare SAI, SICI and ICF among PD patients who cognitively progressed from normal cognitive status to MCI or dementia, and from MCI to dementia.

  Paired-pulse Trans-cranial magnetic stimulation techniques (Short-Latency Afferent Inhibition - SAI), Short-Interval Intracortical Inhibition - SICI, and Intra-Cortical Facilitation - ICF.

  Three timepoints: one, two or three-year follow-up (respectively T1, T2, T3)

• To compare SAI, SICI and ICF among PD patients with different cognitive condition (normal, MCI and dementia).

  Paired-pulse Trans-cranial magnetic stimulation techniques (Short-Latency Afferent Inhibition - SAI), Short-Interval Intracortical Inhibition - SICI, and Intra-Cortical Facilitation - ICF.

  Four timepoints: at baseline (T0), and at one, two or three-year follow-up (respectively T1, T2, T3)

Study Arms (1)

PD patients cognitively normal (PD-CN)

EXPERIMENTAL

PD patients with a normal cognitive functioning and with preserved autonomy in activity of daily living will be subjected to paired-pulse protocols of TMS for the assessment of SAI, SICI and ICF PD patients with a mild cognitive functioning but with a preserved autonomy in activity of daily living will be subjected to paired-pulse protocols of TMS for the assessment of SAI, SICI and ICF

Diagnostic Test: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DIAGNOSTIC_TEST

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

PD patients cognitively normal (PD-CN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Universitaria Integrata del Trentino: lead

Study Sites (3)

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, 39049, Italy

NOT YET RECRUITING

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

Trento, Trentino-Alto Adige, 38122, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Neurologic Manifestations; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Brain Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luigi Cattaneo, MD, PhD

  CIMEC - Centro Interdipartimentale Mente Cervello - Università degli studi di Trento

  STUDY DIRECTOR

• Ruggero Bacchin, MD

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

  PRINCIPAL INVESTIGATOR

• Bruno Giometto, MD

  CISMED - Centro Interdipartimentale di Scienze Mediche - Università degli studi di Trento

  STUDY CHAIR

Central Study Contacts

Ruggero Bacchin, MD

CONTACT

+39-0461903281; ruggero.bacchin@apss.tn.it

Stefania Campostrini, MSc

CONTACT

+39-0461903281; stefania.campostrini@apss.tn.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

IT (3)