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New treatment option for Parkinson Disease
Official title TMS-related Measures as Biomarker of Cognitive Impairment in PD
ClinicalTrials.gov ID: NCT06835595
What this study is testing
- What it's testing
- 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)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Systemic diseases of significant severity, including cardiovascular and cerebrovascular conditions (e.g., active neoplasms requiring chemotherapy, or...
- 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...
- History of epilepsy
- History of cerebrovascular, tumor-related, infectious, or metabolic brain conditions predisposing to seizures or causing symptomatic epilepsy
- Pregnancy or breastfeeding
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Trieste, Friuli Venezia Giulia, Italy
- Sterzing, Trentino-Alto Adige, Italy
- Trento, Trentino-Alto Adige, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trieste, Friuli Venezia Giulia, Italy; Sterzing, Trentino-Alto Adige, Italy; Trento, Trentino-Alto Adige, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.