The Efficacy of HD-tDCS-Augmented Step Training in Older Adults With Mild Dementia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe Hong Kong Polytechnic University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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].

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Step training

    Behavioral

    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-tDCS

    Device

    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-tDCS

    Device

    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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: active HD-tDCS plus step trainingExperimental treatment 2 interventions
Group B: sham HD-tDCS plus step trainingSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)

Secondary outcomes

1

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.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up
2

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.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up
3

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.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up
4

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.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up

Other outcomes

1

The Iconographic Falls Efficacy Scale (Icon-FES) Score

The Iconographic Falls Efficacy Scale (Icon-FES) will be used to assess participants' fear of falling during daily activities. The Icon-FES includes 10 items, each illustrated with a pictogram to facilitate comprehension, especially for individuals with cognitive impairment.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up
2

Geriatric Depression Scale (GDS) Score

Depressive symptoms are assessed using the Geriatric Depression Scale (GDS-15). The scale consists of 15 dichotomous (yes/no) questions evaluating affective status over the past week. Total scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.

Time frame
Baseline, immediate post-intervention, and 3-month follow-up
3

Participant and Caregiver Blinding Integrity Assessment

The success of participant and caregiver blinding is evaluated at the end of the intervention period using a standardized end-of-study guess questionnaire. Participants and their caregivers independently indicate whether they believe the received stimulation was "active", "sham", or if they are "unsure".

Time frame
Immediately post-intervention
4

Perceived Acceptability, Feasibility, and Implementation Determinants Assessed via Qualitative Interviews

Qualitative semi-structured interviews are conducted with participant-caregiver dyads and healthcare professionals/staff to explore intervention feasibility, perceived acceptability, user experiences, and contextual barriers and facilitators to implementation. Audio-recorded transcripts are analyzed to identify key determinants of intervention adoption and translation into community settings.

Time frame
Immediately post-intervention (Week 12)

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