DementiaNCT07841145
The Efficacy of HD-tDCS-Augmented Step Training in Older Adults With Mild Dementia
A study testing Step training and active HD-tDCS in people with Dementia and tDCS, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Falls and mobility decline are major health concerns among older adults with dementia, often linked to deterioration in executive function and cognitive-motor control. Step training interventions that challenge both cognitive and motor faculties have shown promise in enhancing balance and motor reaction to reduce fall… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, tDCS, Physical Exercise
- What is being tested?
- Step training and active HD-tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Interested persons will be included if they are (1) aged 65 years or older; (2) able to walk 10 m without assistance; (3) can communicate in Chinese; and (4) clinically diagnosed with dementia, with mild-stage severity evidenced by a total score of 10 to 18 (inclusive) on the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) [21].
Who cannot join
- Individuals will be excluded if they, or their caregivers, report: (1) severe cardiopulmonary diseases, severe musculoskeletal disorders, or severe visual or hearing impairments; (2) any neurological conditions other than dementia; (3) contraindications to tDCS, including metallic head implants (excluding dental fillings), cardiac pacemakers, skull defects, a history of unprovoked seizures, or skin/scalp lesions at electrode sites; or (4) concurrent or recent physical therapy or non-invasive brain stimulation within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong, None Selected
Secretary of Institutional Review Board, +852 27666379, institutional.review.board@polyu.edu.hk
About this study
Official title: The Efficacy of Combined High-definition Transcranial Direct Current Stimulation (HD-tDCS) and Step Training in Older Adults With Mild Dementia: A Randomized Controlled Trial
Falls and mobility decline are major health concerns among older adults with dementia, often linked to deterioration in executive function and cognitive-motor control. Step training interventions that challenge both cognitive and motor faculties have shown promise in enhancing balance and motor reaction to reduce fall risk. However, long-term retention of training gains remains limited, largely constrained by reduced neuroplasticity and underlying neurodegeneration in this population.
The primary objective of this study is to investigate the efficacy of high-definition transcranial direct current stimulation (HD-tDCS), a form of wearable non-invasive brain stimulation, combined with step training in community-dwelling older adults with mild dementia. Participants will be randomly allocated to either an active HD-tDCS plus step training group or a sham stimulation plus step training control group. Assessments will be conducted at baseline, immediately post-intervention, and at a 3-month follow-up to evaluate changes in cognitive and physical function (including choice stepping reaction time (CSRT), executive function, and dual-task ability) as well as cortical activity during stepping. In addition, a mid-point assessment will be conducted for the primary outcome (i.e., CSRT).
An embedded qualitative evaluation will be conducted with participant-caregiver dyads and healthcare professionals/staff to evaluate implementation outcomes and feasibility (including perceived acceptability, user experience, and practical facilitators and barriers to adoption). Findings from this trial will help optimize neuromodulation-augmented rehabilitation strategies and inform community-based fall prevention programs.
- Conditions
- Dementia, tDCS, Physical Exercise, Neuromodulation, Fall Prevention
- Being tested
- Step training, sham HD-tDCS, active HD-tDCS
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step trainingBehavioural
A structured stepping exercise program will be delivered on a designated stepping mat. The intervention incorporates progressive cognitive tasks (including mental arithmetic, working memory, and executive function challenges) combined with directional volitional stepping. Training difficulty is progressively adapted based on individual performance, with physical and cognitive exertion monitored to maintain a moderate intensity level.
sham HD-tDCSDevice
The sham HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The sham HD-tDCS delivers brief current stimulation to simulate scalp sensations without inducing neuroplastic effects to maintain blinding. All sessions are delivered by trained research personnel following standardized safety guidelines.
active HD-tDCSDevice
The active HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The active HD-tDCS delivers 2 mA current for 20 minutes with ramp-up and ramp-down phases. All sessions are delivered by trained research personnel following standardized safety guidelines.
| Study group | Role | What they receive |
|---|---|---|
| active HD-tDCS plus step training | Experimental | Not described Receives: Behavioral: Step training; Device: active HD-tDCS |
| sham HD-tDCS plus step training | Sham comparator | Not described Receives: Behavioral: Step training; Device: sham HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice Stepping Reaction Time (CSRT) Test Completion Time
The clinical Choice Stepping Reaction Time (CSRT) test evaluates goal-directed volitional stepping speed and accuracy. Participants stand on a designated mat and step onto indicated target panels as quickly and accurately as possible in response to standardized verbal cues across 12 test trials. Performance is recorded as the total time (in seconds) required to successfully complete all 12 correct steps using a stopwatch. Shorter completion times indicate faster reaction and better stepping performance.
Measured: Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)
Secondary outcomes (5)
Dorsolateral Prefrontal Cortex (DLPFC) Hemodynamic Response During Choice Stepping
Cortical activity in the bilateral dorsolateral prefrontal cortex (DLPFC) is assessed during the choice stepping task using functional near-infrared spectroscopy (fNIRS). Performance is quantified by task-evoked changes in oxygenated hemoglobin concentration (ΔHbO) relative to baseline. Greater increases in ΔHbO reflect higher cortical activation and neural recruitment during task execution.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Berg Balance Scale (BBS) Score
Balance will be measured using the Berg Balance Scale (BBS). Participants' ability to maintain an upright posture during 14 functional activities (e.g., sitting, rising from a seated position, transfer between two chairs, reaching while standing) will be rated on a scale ranging from 0 to 4, with higher scores reflecting greater balance.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Maximum Step Length
The Maximum Step Length test (MSLT) assesses an individual's ability to step as far as possible in a given direction (forward, backward, or sideways) and then return to the starting position without losing balance. An average of three attempts for each direction will be recorded.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Single- and Dual-Task TUG Speed
Cognitive-motor dual-tasking ability will be assessed using the single-task and dual-task of the Timed Up and Go (TUG) test. This dual-task TUG combines the standard mobility assessment with a simultaneous verbal fluency task. Under the instruction of a trained assessor, participants will be asked to rise from a standard chair, walk 3 meters, turn around, return to the chair, and sit down as quickly and safely as possible, while simultaneously naming items randomly chosen from a pool of topics (e.g., animals, fruits, or modes of transportation). The total time to complete the task will be recorded. Verbal responses will be monitored to ensure task engagement.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Trail Making Test (TMT) Score
Executive function including attention shift and processing speed will be measured using the Trail Making Test (TMT), an education-fair alternative to the traditional Trail Making Test validated in older adults. The TMT consists of two parts: TMT-A (evaluates visuospatial scanning and perceptual tracking) and TMT-B (evaluates executive divided attention and mental set-shifting). TMT-A requires participants to connect numbers in an ascending sequence (i.e., numbers 1-25) enclosed in uniform circles. TMT-B requires participants to connect numbers in an ascending sequence while alternating between two distinct geometric shapes (circles and squares, e.g., 1-circle to 2-square to 3-circle). Shorter completion times indicated better performance.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
- Investigators
- Marco YC Pang, Chair professor, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841145
- Sponsor's protocol ID
- HSEARS20260914015
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combined High-definition Transcranial Direct Current Stimulation (HD-tDCS) and Step Training in Older Adults With Mild Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07841145
- Acronym / sponsor ID
- HSEARS20260914015
- Conditions
- Dementia, tDCS, Physical Exercise, Neuromodulation, Fall Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls and mobility decline are major health concerns among older adults with dementia, often linked to deterioration in executive function and cognitive-motor control. Step training interventions that challenge both cognitive and motor faculties have shown promise in enhancing balance and motor reaction to reduce fall risk. However, long-term retention of training gains remains limited, largely constrained by reduced neuroplasticity and underlying neurodegeneration in this population.
The primary objective of this study is to investigate the efficacy of high-definition transcranial direct current stimulation (HD-tDCS), a form of wearable non-invasive brain stimulation, combined with step training in community-dwelling older adults with mild dementia. Participants will be randomly allocated to either an active HD-tDCS plus step training group or a sham stimulation plus step training control group. Assessments will be conducted at baseline, immediately post-intervention, and at a 3-month follow-up to evaluate changes in cognitive and physical function (including choice stepping reaction time (CSRT), executive function, and dual-task ability) as well as cortical activity during stepping. In addition, a mid-point assessment will be conducted for the primary outcome (i.e., CSRT).
An embedded qualitative evaluation will be conducted with participant-caregiver dyads and healthcare professionals/staff to evaluate implementation outcomes and feasibility (including perceived acceptability, user experience, and practical facilitators and barriers to adoption). Findings from this trial will help optimize neuromodulation-augmented rehabilitation strategies and inform community-based fall prevention programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active HD-tDCS plus step training | Experimental | Behavioral: Step training, Device: active HD-tDCS |
| sham HD-tDCS plus step training | Sham comparator | Behavioral: Step training, Device: sham HD-tDCS |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Interested persons will be included if they are (1) aged 65 years or older; (2) able to walk 10 m without assistance; (3) can communicate in Chinese; and (4) clinically diagnosed with dementia, with mild-stage severity evidenced by a total score of 10 to 18 (inclusive) on the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) [21].
Key exclusion criteria (1 listed)
- Individuals will be excluded if they, or their caregivers, report: (1) severe cardiopulmonary diseases, severe musculoskeletal disorders, or severe visual or hearing impairments; (2) any neurological conditions other than dementia; (3) contraindications to tDCS, including metallic head implants (excluding dental fillings), cardiac pacemakers, skull defects, a history of unprovoked seizures, or skin/scalp lesions at electrode sites; or (4) concurrent or recent physical therapy or non-invasive brain stimulation within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step trainingA structured stepping exercise program will be delivered on a designated stepping mat. The intervention incorporates progressive cognitive tasks (including mental arithmetic, working memory, and executive function challenges) combined with directional volitional stepping. Training difficulty is progressively adapted based on individual performance, with physical and cognitive exertion monitored to maintain a moderate intensity level. | Behavioural | active HD-tDCS plus step training, sham HD-tDCS plus step training |
| sham HD-tDCSThe sham HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The sham HD-tDCS delivers brief current stimulation to simulate scalp sensations without inducing neuroplastic effects to maintain blinding. All sessions are delivered by trained research personnel following standardized safety guidelines. | Device | sham HD-tDCS plus step training |
| active HD-tDCSThe active HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The active HD-tDCS delivers 2 mA current for 20 minutes with ramp-up and ramp-down phases. All sessions are delivered by trained research personnel following standardized safety guidelines. | Device | active HD-tDCS plus step training |
Primary outcome
Choice Stepping Reaction Time (CSRT) Test Completion Time
Time frame: Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)
The clinical Choice Stepping Reaction Time (CSRT) test evaluates goal-directed volitional stepping speed and accuracy. Participants stand on a designated mat and step onto indicated target panels as quickly and accurately as possible in response to standardized verbal cues across 12 test trials. Performance is recorded as the total time (in seconds) required to successfully complete all 12 correct steps using a stopwatch. Shorter completion times indicate faster reaction and better stepping performance.
5 secondary outcomes
Dorsolateral Prefrontal Cortex (DLPFC) Hemodynamic Response During Choice Stepping
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Berg Balance Scale (BBS) Score
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Maximum Step Length
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Single- and Dual-Task TUG Speed
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Trail Making Test (TMT) Score
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco YC Pang, Chair professor principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step training and active HD-tDCS in people with Dementia and tDCS, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae QJ LIU, PhD Student (61934110, jae.liu@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice Stepping Reaction Time (CSRT) Test Completion Time (time frame: Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.