Actively Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Led by Amsterdam UMC · Updated on 2024-07-16
20
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Parkinson's disease by a neurologist
- Mild to moderate disease stage (Hoehn & Yahr stage less than 4)
- Meets Movement Disorders Society level I criteria for PD-MCI, including Montreal Cognitive Assessment score between 21 and 25, or performance 1-2 standard deviations below norms on at least 2 neuropsychological tests, or recent classification of PD-MCI within 6 months
- On stable dopaminergic medication for at least one month prior and expected to remain stable during the study
You will not qualify if you...
- Signs of dementia based on SAGE test (score 14 or less)
- Severe depressive disorder (Beck Depression Inventory - Ib score greater than 18)
- Psychotic disorder except benign hallucinations with insight
- Alcohol or drug abuse
- Contraindications for rTMS including presence of cardiac pacemakers, implanted medical devices, metal implants, broken skin at stimulation site, large ischemic scars, pregnancy, epilepsy, family history of convulsions, brain lesions affecting seizure threshold, multiple sclerosis, certain medications, sleep deprivation, heavy alcohol use, severe heart disease, increased intracranial pressure, uncontrolled migraines
- Contraindications for tDCS including history of seizures, unexplained loss of consciousness, unstable neuropsychiatric illness, implanted brain or cardiac devices, skin problems at stimulation sites, severe headaches, serious life-threatening diseases, pregnancy
- Contraindications for MRI such as metal in body, previous brain surgery, head trauma with unconsciousness over 1 hour, clips, tattoos with metal, piercings, metal braces, pregnancy, claustrophobia, neurostimulator devices
- Presence of space-occupying brain lesions on MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Actively Recruiting
Research Team
T
Tim D van Balkom, PhD
CONTACT
C
Chris Vriend, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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