NCT06559254

TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hospital Authority, Hong Kong · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 1:1 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 (e.g. 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 1:1 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 (e.g. 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.

Conditions

• Major Neurocognitive Disorder

Interventions

Type	Name	Description
DEVICE	transcranial direct current stimulation	Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation by applying weak current through electrode. It can archive excitation by anode stimulation or inhibition by stimulating cathode. By inducing modification of membrane polarisation, it can modulate cerebral excitability. Literature suggested anode tDCS over the dorsolateral prefrontal cortex (DLPFC) improved cognitive function, in terms of responding faster and more accurate in cognitive tasks. tDCS was well tolerated and accepted by participants.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-04-30
• Completion: 2025-09-30
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

1 site across 1 country: Hong Kong