Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder

REM Sleep Behavior Disorder Clinical Trial

Official title:

Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05256836
• Other study ID #: 2105-117-1220
• Status: Suspended
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.

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 information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Other:
• Tablet computer-based cognitive training program
The subject of the study executes a program mounted on a tablet personal computer (PC) (Samsung Galaxy Tab S6 Lite) and performs a cognitive training task by touching the screen with the index finger. It consists of 10 tasks related to the activity of daily living: 1) taking medicine, 2) making a phone call, 3) taking a shower, 4) doing laundry, 5) finding directions, 6) riding the bus, 7) buying goods, 8) Money management, 9) ingredient sorting, 10) meal preparation. It is involved in cognitive functions in various domains such as attention, working memory, processing speed, problem solving, visuospatial ability, verbal and visuospatial memory. There are three levels of difficulty for each task, high, medium, and low, and the difficulty becomes more difficult as session 1 to 36 progresses. One cognitive training session lasts about 30 minutes.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score	Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)	Change from baseline CERAD-K total score at 12 weeks
Secondary	Change in CERAD-K attention score	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 outcome	Change from baseline CERAD-K attention score at 12 weeks
Secondary	Change in CERAD-K memory score	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 outcome	Change from baseline CERAD-K memory score at 12 weeks
Secondary	Change in CERAD-K language score	Scores for each of the 5 domains 3.Language; - Boston naming test (0~15): higher scores mean a better outcome	Change from baseline CERAD-K language score at 12 weeks
Secondary	Change in CERAD-K visuospatial function score	Scores for each of the 5 domains 4.Visuospatial function; - Constructional behavior (0~11): higher scores mean a better outcome	Change from baseline CERAD-K visualspatial function score at 12 weeks
Secondary	Change in CERAD-K executive function score	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 outcome	Change from baseline CERAD-K executive function score at 12 weeks
Secondary	Change in mini-mental status examination in the Korean version (MMSE-K) score	minimum value: 0, maximum value: 30 (higher scores mean a better outcome)	Change from baseline MMSE-K score at 12 weeks
Secondary	Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score	minimum value: 0, maximum value: 30 (higher scores mean a better outcome)	Change from baseline MoCA-K score at 12 weeks
Secondary	Change in resting electroencephalography (EEG) power spectrum	distribution of power into frequency components composing the signal (delta, theta, alpha, beta)	Change from baseline EEG power spectrum at 12 weeks
Secondary	Change in resting electroencephalography (EEG) weighted phase lag index	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 from baseline EEG weighted phase lag index at 12 weeks
Secondary	Change in event-related potential (ERP) reaction time	time (ms) from target presentation to button press	Change from baseline ERP reaction time at 12 weeks
Secondary	Change in event-related potential (ERP) hit rate	the probability that an old item is either correctly recognized, or not	Change from baseline ERP hit rate at 12 weeks
Secondary	Change in event-related potential (ERP) N2 amplitude	The N2 peak (µV) is a fronto-central maximal negativity observed approximately 150-400 ms after stimulus onset	Change from baseline ERP N2 amplitude at 12 weeks
Secondary	Change in event-related potential (ERP) time-frequency analysis	Indicates the power of the EEG frequency at a specific time	Change from baseline ERP time-frequency analysis at 12 weeks