Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
- Conditions
- REM Sleep Behavior Disorder
- Interventions
- Other: Tablet computer-based cognitive training program
- Registration Number
- NCT05256836
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.
- Detailed Description
Rapid eye movement (REM) sleep behavior disorder (RBD) is a parasomnia characterized by abnormal movement to reproduce dreams and loss of skeletal muscle tension during REM sleep. Idiopathic RBD (iRBD) refers to the absence of any predisposing factors or comorbid neurological disorders. iRBD is considered the prodromal stage of alpha-synucleinopathy.
Through past studies, it has been confirmed that cognitive function decline has already occurred in a significant number of iRBD patients. However, there is still no treatment that can suppress or delay the onset of neurodegenerative diseases.
The cognitive function improvement effect of computerized cognitive training in the elderly and patients with mild cognitive impairment is known. However, the effect of cognitive training on improving cognitive function in iRBD patients has not been studied.
The investigators developed a program that allows patients to train cognitive functions in various domains by repeatedly performing tasks related to daily life activities. In addition, by loading the program on the tablet computer, it is possible to participate in the training easily at home using the touch screen without visiting the hospital.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 60
- Patients aged 60-80 years old who have been diagnosed with iRBD through nocturnal polysomnography according to the International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria
- Those who gave their written consent to participate in the study
- Patients with neurodegenerative diseases including Parkinson's disease, dementia, and multiple system atrophy
- Patients with secondary causes of RBD
- Patients with severe hearing, visual impairment, or motor impairment
- Patients who have received cognitive training within the last year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tablet group Tablet computer-based cognitive training program A total of 36 sessions per week for 12 weeks of cognitive training program using a tablet computer are performed.
- Primary Outcome Measures
Name Time Method Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score Change from baseline CERAD-K total score at 12 weeks Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)
- Secondary Outcome Measures
Name Time Method Change in CERAD-K memory score Change from baseline CERAD-K memory score at 12 weeks Scores for each of the 5 domains 2.Memory
* Word registration (0\~30): higher scores mean a better outcome
* Word recall (0\~10): higher scores mean a better outcome
* Word recognition (0\~10): higher scores mean a better outcome
* Constructional recall (0\~11): higher scores mean a better outcomeChange in CERAD-K language score Change from baseline CERAD-K language score at 12 weeks Scores for each of the 5 domains 3.Language
- Boston naming test (0\~15): higher scores mean a better outcomeChange in mini-mental status examination in the Korean version (MMSE-K) score Change from baseline MMSE-K score at 12 weeks minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Change in event-related potential (ERP) hit rate Change from baseline ERP hit rate at 12 weeks the probability that an old item is either correctly recognized, or not
Change in CERAD-K visuospatial function score Change from baseline CERAD-K visualspatial function score at 12 weeks Scores for each of the 5 domains 4.Visuospatial function
- Constructional behavior (0\~11): higher scores mean a better outcomeChange in Korean version of Montreal Cognitive Assessment (MoCA-K) score Change from baseline MoCA-K score at 12 weeks minimum value: 0, maximum value: 30 (higher scores mean a better outcome)
Change in resting electroencephalography (EEG) weighted phase lag index Change from baseline EEG weighted phase lag index at 12 weeks a functional connectivity measure that quantified how consistently 90° (or 270°) phase 'lagging' one EEG signal was compared to another (From 0 to 1, if it is close to 1, the connectivity is high)
Change in event-related potential (ERP) reaction time Change from baseline ERP reaction time at 12 weeks time (ms) from target presentation to button press
Change in CERAD-K executive function score Change from baseline CERAD-K executive function score at 12 weeks Scores for each of the 5 domains 5.Executive function
* Trail making test B (0\~300): higher scores mean a worse outcome
* Language fluency (0\~): higher scores mean a better outcome
* Stroop test (word/color) (0\~): higher scores mean a better outcomeChange in resting electroencephalography (EEG) power spectrum Change from baseline EEG power spectrum at 12 weeks distribution of power into frequency components composing the signal (delta, theta, alpha, beta)
Change in CERAD-K attention score Change from baseline CERAD-K attention score at 12 weeks Scores for each of the 5 domains
1.Attention
* Trail making test A (0\~360): higher scores mean a worse outcome
* Stroop test (word) (0\~): higher scores mean a better outcomeChange in event-related potential (ERP) N2 amplitude Change from baseline ERP N2 amplitude at 12 weeks The N2 peak (μV) is a fronto-central maximal negativity observed approximately 150-400 ms after stimulus onset
Change in event-related potential (ERP) time-frequency analysis Change from baseline ERP time-frequency analysis at 12 weeks Indicates the power of the EEG frequency at a specific time
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of