RecruitingNot ApplicableNCT06399731

Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease: an Acceptability Cross-over Study

Sponsor

Amsterdam UMC

Enrollment

20 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Mild Cognitive Impairment

Summary

This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design. They sequentially undergo four consecutive phases (4 weeks each), 1) no-intervention baseline, 2) rTMS ór tDCS, 3) no-intervention, 4) second intervention. The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether non-invasive brain stimulation techniques (TMS and tDCS — devices that deliver gentle electrical or magnetic pulses to the scalp) can improve memory and thinking in people with Parkinson's disease who also have mild cognitive impairment (early-stage thinking problems). **You may be eligible if...** - You have been diagnosed with Parkinson's disease by a neurologist - Your disease is at a mild to moderate stage - You have mild cognitive impairment (early thinking or memory difficulties) - If you take Parkinson's medications, your dose has been stable for at least one month **You may NOT be eligible if...** - You have dementia - You have severe depression - You have a psychotic disorder - You have a pacemaker, deep brain stimulator, cochlear implant, or other electronic implant - You have metal in your head or body - You are pregnant - You have epilepsy or a history of seizures - You have claustrophobia or cannot lie still for 45 minutes (needed for MRI) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHigh-frequency (10Hz) rTMS

High-frequency (10 Hz) rTMS targeting the left DLPFC, based on fMRI-peak activation during performance of the Tower of London task, at 110% resting motor threshold intensity, corrected for scalp-cortex distance at the target location, for a total of 3000 pulses per session, using 30 trains of 10 seconds with 30-second inter-train intervals (total duration: 20 minutes), using neuronavigation to record the pulse location.

DEVICEAnodal tDCS

Anodal high-definition tDCS. The anode will be placed at the F3 EEG location, coordinates registered using neuronavigation on the first intervention session on-site, and cathodes at Fp1, Fz, C3 and F7, in a ring surrounding the anode, using π cm2 circular stimulation electrodes, stimulating the left DLPFC at 2 mA intensity for a duration of 20 minutes, 15 s ramp up and 15 s ramp down. After an initial on-site instructional tDCS session, the tDCS intervention will be delivered at home, in part remotely-supervised via MS Teams.