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

NCT07841145 | Not Yet Recruiting

• 1 other identifier: HSEARS20260914015
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

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.

  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

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

• Berg Balance Scale (BBS) Score

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

• Maximum Step Length

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

• Single- and Dual-Task TUG Speed

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

• Trail Making Test (TMT) Score

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

Other Outcomes (4)

• The Iconographic Falls Efficacy Scale (Icon-FES) Score

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

• Geriatric Depression Scale (GDS) Score

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

• Participant and Caregiver Blinding Integrity Assessment

  Immediately post-intervention

Study Arms (2)

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

Interventions

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.

active HD-tDCS plus step training; sham HD-tDCS plus step training

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.

sham HD-tDCS plus step training

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.

active HD-tDCS plus step training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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) \[21\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, None Selected, Hong Kong

Location

MeSH Terms

Conditions

Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Marco YC Pang, Chair professor

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae QJ LIU, PhD Student

CONTACT

61934110; jae.liu@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

HK (1)