TMS-related Measures as Biomarker of Cognitive Impairment in PD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Sanitaria Universitaria Integrata del Trentino

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcranial Magnetic Stimulation

    Diagnostic test

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

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: PD patients cognitively normal (PD-CN)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Three timepoints: one, two or three-year follow-up (respectively T1, T2, T3)
2

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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