Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559254
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of Transcranial Direct Current Stimulation tDCS as Augmentation Therapy to Cognitive Training CT in Individuals With Major Neurocognitive Disorder MND of Mild Severity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to increase in life expectancy major neurocognitive disorder MND becoming increasingly important as reflected in the increasing number in dementia population as well as in burden to health care system and to caregiver
Among current treatment cognitive training has shown to have significant outcome in cognitive impaired patient But the effect is reported to be small and might not be long-lasting In consideration of the neuronal excitability effect in tDCS it may consolidate the effect of cognitive training if used simultaneously The study will investigate on efficacy of tDCS as combined intervention to cognitive training
The study aims to investigate the efficacy of 2-week 5 sessions per week tDCS to augment cognitive training in subjects with MND with clinically mild severity Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed The eligible participants will be randomized to receive either active intervention active tDCS or sham sham tDCS as control with cognitive training simultaneously
Each session lasts for 20 minutes The subjects will be allocated to either interventional or control group using block randomization Block of 4 will be used to allocate subjects at 11 ratio between two groups Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation Primary and secondary outcome will be assessed at baseline week 2 after course of intervention and 4 weeks after the course of intervention Baseline assessment assesses on demographic data eg age gender years of education clinical data with full psychiatric assessment and access to previous medical record neuropsychiatric data HK-MoCA and CNPI Primary outcomes includes N-back cognitive training performance forward and backward digit span Secondary outcomes includes measurement on dementia rating and trail making test In data analysis any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points Potential confounders will be adjusted
Baseline assessments and outcome measures is either psychiatric assessment clinician rating scales or cognitive assessment performed with investigator
Among current treatment cognitive training has shown to have significant outcome in cognitive impaired patient But the effect is reported to be small and might not be long-lasting In consideration of the neuronal excitability effect in tDCS it may consolidate the effect of cognitive training if used simultaneously The study will investigate on efficacy of tDCS as combined intervention to cognitive training
The study aims to investigate the efficacy of 2-week 5 sessions per week tDCS to augment cognitive training in subjects with MND with clinically mild severity Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed The eligible participants will be randomized to receive either active intervention active tDCS or sham sham tDCS as control with cognitive training simultaneously
Each session lasts for 20 minutes The subjects will be allocated to either interventional or control group using block randomization Block of 4 will be used to allocate subjects at 11 ratio between two groups Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation Primary and secondary outcome will be assessed at baseline week 2 after course of intervention and 4 weeks after the course of intervention Baseline assessment assesses on demographic data eg age gender years of education clinical data with full psychiatric assessment and access to previous medical record neuropsychiatric data HK-MoCA and CNPI Primary outcomes includes N-back cognitive training performance forward and backward digit span Secondary outcomes includes measurement on dementia rating and trail making test In data analysis any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points Potential confounders will be adjusted
Baseline assessments and outcome measures is either psychiatric assessment clinician rating scales or cognitive assessment performed with investigator
Detailed Description:
Due to increase in life expectancy major neurocognitive disorder MND becoming increasingly important as reflected in the increasing number in dementia population as well as in burden to health care system and to caregiver
Among current treatment cognitive training has shown to have significant outcome in cognitive impaired patient But the effect is reported to be small and might not be long-lasting In consideration of the neuronal excitability effect in tDCS it may consolidate the effect of cognitive training if used simultaneously The study will investigate on efficacy of tDCS as combined intervention to cognitive training
The study aims to investigate the efficacy of 2-week 5 sessions per week tDCS to augment cognitive training in subjects with major neurocognitive disorder with clinically mild severity Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed The eligible participants will be randomized to receive either active intervention active tDCS or sham sham tDCS as control with cognitive training simultaneously
Each session lasts for 20 minutes The subjects will be allocated to either interventional group or control group using block randomization Block of 4 will be used to allocate subjects at 11 ratio between two groups Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation Primary outcome and secondary outcome will be assessed at baseline week 2 after course of intervention and 4 weeks after the course of intervention Baseline assessment assesses on demographic data eg age gender years of education clinical data with full psychiatric assessment and access to previous medical record neuropsychiatric data HK-MoCA and CNPI Primary outcomes includes N-back cognitive training performance forward and backward digit span Secondary outcomes includes measurement on dementia rating and trail making test In data analysis any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points Potential confounders will be adjusted
Baseline assessments and outcome measures is either psychiatric assessment clinician rating scales or cognitive assessment performed with investigator No questionnaires will be given to participants
Among current treatment cognitive training has shown to have significant outcome in cognitive impaired patient But the effect is reported to be small and might not be long-lasting In consideration of the neuronal excitability effect in tDCS it may consolidate the effect of cognitive training if used simultaneously The study will investigate on efficacy of tDCS as combined intervention to cognitive training
The study aims to investigate the efficacy of 2-week 5 sessions per week tDCS to augment cognitive training in subjects with major neurocognitive disorder with clinically mild severity Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed The eligible participants will be randomized to receive either active intervention active tDCS or sham sham tDCS as control with cognitive training simultaneously
Each session lasts for 20 minutes The subjects will be allocated to either interventional group or control group using block randomization Block of 4 will be used to allocate subjects at 11 ratio between two groups Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation Primary outcome and secondary outcome will be assessed at baseline week 2 after course of intervention and 4 weeks after the course of intervention Baseline assessment assesses on demographic data eg age gender years of education clinical data with full psychiatric assessment and access to previous medical record neuropsychiatric data HK-MoCA and CNPI Primary outcomes includes N-back cognitive training performance forward and backward digit span Secondary outcomes includes measurement on dementia rating and trail making test In data analysis any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points Potential confounders will be adjusted
Baseline assessments and outcome measures is either psychiatric assessment clinician rating scales or cognitive assessment performed with investigator No questionnaires will be given to participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None