TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia
NCT Number: NCT06559254
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Neurocognitive Disorder
Interventions: DEVICE: transcranial direct current stimulation
Sponsor: Hospital Authority, Hong Kong
Collaborators: The University of Hong Kong
Sex: ALL
Age: OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-30
Locations: Queen Mary Hospital, Hong Kong, Hong Kong

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.

Primary Outcome Measures: N-back task performance in terms of reaction time and % of correct, N-back task performance in terms of reaction time and % of correct. The data will be measured in the computerized programme., Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention|Forward and Backward digit span, Digit span is widely used to test verbal working memory. It can be assessed in forward (forward digit span) and reverse order (backward digit span). It is also a component in Wechsler Adult Intelligence Scale., Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Secondary Outcome Measures: Clinical dementia rating - sum of boxes, Clinical dementia rating (CDR) is a 5-point scale to assess six domains of cognitive and functional performance. The Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) has increased utility in detecting difference between stages of dementia severity., Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention|Chinese version of the neuropsychiatric inventory (CNPI), CNPI is developed by Cummings et al. It assesses 12 aspects in neuropsychiatric disturbances, e.g. agitation, anxiety, irritability. The modified version of NPI also evaluate carer distress., Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention|Trail making test, Trail Making Test (TMT) is widely used test to assess attention, psychomotor speed and mental flexibility. Trail making test - black and white (TMT-B\&W) used numbers in circle with black and white background instead of use of the English alphabet in Trail Making Test part B (TMT B). It is more user friendly in individuals would might not be able to read English letters., Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention