Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399731
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinsons Disease
Sponsor:
Amsterdam UMC
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinsons Disease an Acceptability Cross-over Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NESCIO-PD
Brief Summary:
This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinsons 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
Detailed Description:
RATIONALE Mild cognitive impairment MCI is a highly prevalent non-motor characteristic affecting about 40 of individuals with Parkinsons disease PD PD-MCI negatively impacts daily life functioning and quality of life and is associated with presence of other neuropsychiatric symptoms Importantly it constitutes a risk factor for later development of PD-related dementia
Despite many endeavours to pharmacologically improve PD-MCI there is currently no effective treatment Optimization of dopaminergic therapy in early PD can relieve cognitive deficits improving cognitive inflexibility and bradyphrenia but also exacerbating other cognitive domains Additionally other non-pharmacological treatment options such as cognitive training have shown moderate effect sizes but with limited transfer to daily functioning
Non-invasive brain stimulation NIBS through repetitive transcranial magnetic stimulation rTMS or transcranial direct current stimulation tDCS has promise in treating PD-MCI NIBS particularly institute-based rTMS is however intensive and complex in use specifically for individuals with motor and cognitive difficulties which might limit its potential for clinical use
OBJECTIVE To study the acceptability and feasibility of rTMS and tDCS for the treatment of individuals with PD-MCI
STUDY DESIGN A cross-over design with three conditions a baseline condition rTMS and tDCS The study consists of 1 two four-week intervention periods with rTMS treatment three times a week total session duration 40 mins treatment duration 20 mins and tDCS treatment five times a week total session duration 30 mins treatment duration 20 mins For the rTMS intervention stimulation will be performed at the Amsterdam UMC location VUmc and thus includes travel time 2 one 120-minute assessment baseline that includes neuropsychological and motor assessment and MR imaging and four 60-minute assessments that only includes neuropsychological assessment
STUDY POPULATION We will enroll twenty individuals with PD-MCI according to level I criteria by the Movement Disorders Society Montreal Cognitive Assessment score range 21-25 performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests or recent 6 months classification of PD-MCI on neuropsychological assessment elsewhere
INTERVENTION Participants will undergo four consecutive phases in this intervention study 1 a no-intervention baseline phase 2 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation rTMS 10 Hz or 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation tDCS targeting the left dorsolateral prefrontal cortex DLPFC 3 a second no-intervention baseline phase 4 the second alternative NIBS intervention All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced
MAIN STUDY PARAMETERS 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
Despite many endeavours to pharmacologically improve PD-MCI there is currently no effective treatment Optimization of dopaminergic therapy in early PD can relieve cognitive deficits improving cognitive inflexibility and bradyphrenia but also exacerbating other cognitive domains Additionally other non-pharmacological treatment options such as cognitive training have shown moderate effect sizes but with limited transfer to daily functioning
Non-invasive brain stimulation NIBS through repetitive transcranial magnetic stimulation rTMS or transcranial direct current stimulation tDCS has promise in treating PD-MCI NIBS particularly institute-based rTMS is however intensive and complex in use specifically for individuals with motor and cognitive difficulties which might limit its potential for clinical use
OBJECTIVE To study the acceptability and feasibility of rTMS and tDCS for the treatment of individuals with PD-MCI
STUDY DESIGN A cross-over design with three conditions a baseline condition rTMS and tDCS The study consists of 1 two four-week intervention periods with rTMS treatment three times a week total session duration 40 mins treatment duration 20 mins and tDCS treatment five times a week total session duration 30 mins treatment duration 20 mins For the rTMS intervention stimulation will be performed at the Amsterdam UMC location VUmc and thus includes travel time 2 one 120-minute assessment baseline that includes neuropsychological and motor assessment and MR imaging and four 60-minute assessments that only includes neuropsychological assessment
STUDY POPULATION We will enroll twenty individuals with PD-MCI according to level I criteria by the Movement Disorders Society Montreal Cognitive Assessment score range 21-25 performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests or recent 6 months classification of PD-MCI on neuropsychological assessment elsewhere
INTERVENTION Participants will undergo four consecutive phases in this intervention study 1 a no-intervention baseline phase 2 12 sessions of 20-minute institute-based repetitive transcranial magnetic stimulation rTMS 10 Hz or 20 sessions of 20-minute at-home anodal high-definition transcranial direct current stimulation tDCS targeting the left dorsolateral prefrontal cortex DLPFC 3 a second no-intervention baseline phase 4 the second alternative NIBS intervention All phases have a duration of 4 weeks and the order of the NIBS interventions is counterbalanced
MAIN STUDY PARAMETERS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10390052210003 | OTHER_GRANT | None | None |
| NL8484301823 | REGISTRY | ToetsingOnline | None |