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

ConditionsParkinson Disease Mild Cognitive Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorAmsterdam UMC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of Parkinson's disease, diagnosed by a neurologist;

Mild to moderate disease stage (Hoehn & Yahr disease stage < 4);

Montreal Cognitive Assessment score range [21-25] (Dalrymple-Alford et al., 2010), or

performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or

Disqualifiers

Indication for dementia based on the SAGE (cut-off ≤ 14; Scharre et al., 2010);

Severe depressive disorder (Beck Depression Inventory - Ib score > 18);

Psychotic disorder (except for benign hallucinations with insight), screened with the Scale for Assessment of Positive Symptoms for Parkinson's disease;

Indication of alcohol or drug abuse;

Trial design

Design model

Crossover

Treatments tested in this trial

High-frequency (10Hz) rTMS
Device
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.
Anodal tDCS
Device
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Intervention arm 1: rTMS followed by tDCSExperimental treatment 2 interventions

Group B: Intervention arm 2: tDCS followed by rTMSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Quantative acceptability of the interventions (measured seperately)

Measured with Theoretical Framework of Acceptability questionnaire ("TFA-PD questionnaire") score, measuring seven domains of acceptability

Time frame

Eight weeks and sixteen weeks (after first and second intervention)

Secondary outcomes

Qualitative acceptability assessment of both interventions

Qualitative assessment from focus groups after study termination

Time frame

After study termination (i.e., all participants finished)

Intervention compliance (feasibility)

Percent of missed intervention sessions

Time frame

Eight weeks and sixteen weeks (during first and second intervention)

Intervention attrition (feasibility)

Count of dropped out participants

Time frame

After study termination (i.e., all participants finished)

Usability of the tDCS device (feasibility)

System Usability Scale score

Time frame

Eight weeks or sixteen weeks (after tDCS intervention)

Other outcomes

Structural and functional connectivity

Measured with MPRAGE, resting-state fMRI, task-based fMRI, DWI

Time frame

Baseline

Distance to optimal DLPFC stimulation target

Measured with optimal voxel coordinate based on task-based fMRI

Time frame

Baseline

Age

Time frame

Baseline

Sex

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC

Lead sponsor

Source ClinicalTrials.gov

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