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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

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

• Movement Disorders Society level I criteria for PD-MCI (Litvan et al., 2012):

‣ 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

⁃ classification of PD-MCI based on recent (\< 6 months previous to participation) neuropsychological assessment taken elsewhere (report will be requested);- In case of (dopaminergic) medication use, participants are on stable medication for at least one month before participation and expect to remain on stable medication during the study

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Tim D van Balkom, PhD
t.vanbalkom@amsterdamumc.nl
+31204441162
Backup
Chris Vriend, PhD
c.vriend@amsterdamumc.nl
+31204441162
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 20
Treatments
Experimental: Intervention arm 1: rTMS followed by tDCS
Participants in intervention arm 1 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC. All phases have a duration of 4 weeks.
Experimental: Intervention arm 2: tDCS followed by rTMS
Participants in intervention arm 2 will undergo four phases in the following order: 1) a no-intervention baseline phase, 2) 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation (tDCS) targeting the left DLPFC, 3) a second no-intervention baseline phase, 4) 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation (rTMS) (10 Hz) targeting the left DLPFC. All phases have a duration of 4 weeks.
Related Therapeutic Areas
Sponsors
Leads: Amsterdam UMC

This content was sourced from clinicaltrials.gov