Clinical trial NCT06559254: TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Neurocognitive Disorder
Keywords: mild dementia
major neurocognitive disorder
tdcs
transcranial direct current stimulation
cognitive training
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2024-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or above
* Right-handedness Chinese as defined by Edinburgh handedness inventory
* Cantonese speaking
* Fulfil the criteria of Major neurocognitive disorder, as defined by the 5 th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM- 5)
* Clinical Dementia Rating Global score = 1

Exclusion Criteria:

* Active diagnosis of mood disorder or psychosis
* Alcohol or substance dependence
* Initiation or change in dose of cognitive enhancer within 6 months prior to the onset of the study 14
* Poor physical condition and mobility
* Having regular cognitive training (as defined by at least three 1-hour weekly structured and standardized cognitive training in recent 3 months) 15
* Receiving tDCS within 2 months prior to the onset of study 16
* Significant communication or visual impairment
* Having metal implant in area above upper back, or having metal crown or metal brace, or pacemaker

Primary outcomes:
measure: N-back task performance in terms of reaction time and % of correct
timeFrame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
measure: Forward and Backward digit span
timeFrame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Secondary outcomes:
measure: Clinical dementia rating - sum of boxes
timeFrame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
measure: Chinese version of the neuropsychiatric inventory (CNPI)
timeFrame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
measure: Trail making test
timeFrame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Pak Wing Cheng, MBBS, HKU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Baek MJ, Kim S. Alternative type of the trail making test in nonnative English-speakers: the trail making test-black & white. PLoS One. 2014 Feb 13;9(2):e89078. doi: 10.1371/journal.pone.0089078. eCollection 2014.
citation: Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
citation: Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
citation: Cruz Gonzalez P, Fong KNK, Chung RCK, Ting KH, Law LLF, Brown T. Can Transcranial Direct-Current Stimulation Alone or Combined With Cognitive Training Be Used as a Clinical Intervention to Improve Cognitive Functioning in Persons With Mild Cognitive Impairment and Dementia? A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2018 Oct 16;12:416. doi: 10.3389/fnhum.2018.00416. eCollection 2018.
citation: Lampit A, Hallock H, Suo C, Naismith SL, Valenzuela M. Cognitive training-induced short-term functional and long-term structural plastic change is related to gains in global cognition in healthy older adults: a pilot study. Front Aging Neurosci. 2015 Mar 9;7:14. doi: 10.3389/fnagi.2015.00014. eCollection 2015.
citation: Jones RW. Have cholinergic therapies reached their clinical boundary in Alzheimer's disease? Int J Geriatr Psychiatry. 2003 Sep;18(Suppl 1):S7-S13. doi: 10.1002/gps.936.
citation: Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14.
citation: Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.
citation: Tricco AC, Ashoor HM, Soobiah C, Rios P, Veroniki AA, Hamid JS, Ivory JD, Khan PA, Yazdi F, Ghassemi M, Blondal E, Ho JM, Ng CH, Hemmelgarn B, Majumdar SR, Perrier L, Straus SE. Comparative Effectiveness and Safety of Cognitive Enhancers for Treating Alzheimer's Disease: Systematic Review and Network Metaanalysis. J Am Geriatr Soc. 2018 Jan;66(1):170-178. doi: 10.1111/jgs.15069. Epub 2017 Sep 29.