Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
NCT Number: NCT06581458
Acronym: HometDCS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Motoric Cognitive Risk Syndrome
Interventions: DRUG: tDCS
Sponsor: Tel-Aviv Sourasky Medical Center
Sex: ALL
Age: OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2026-09

Summary:
1. To examine the effect of a two-week tDCS intervention of 3 months of continued tDCS intervention versus 3 months of receiving a placebo treatment (dummy). On the costs of performing an action task (dual task cost) walking speed, cognitive measures and motor function.
2. To examine whether the effects of tDCS build up over time by creating a delayed start mechanism in the intervention (delayed-start design)
3. Examining mechanical and neuroplastic effects of tDCS intervention
4. To examine the response to tDCS over time

Primary Outcome Measures: Accuracy in Serial Subtractions Task, articipants will perform serial subtractions from a random 3-digit number between 200 and 999. Accuracy will be measured as the percentage of correct subtractions., 45-second|Usual walk, fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle., 45-second|Walk with the cognitive task (DT), fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle., 45-second
Secondary Outcome Measures: Mobility - SPPB (Short Physical Performance Battery), Evaluating participants' physical performance through a battery of tests including balance, walking speed, and chair stand tests., 9 months|Mobility - 4 m Gait Test, Measuring participants' gait speed over a 4-meter distance., 9 months|Mobility - Falls Efficacy Scale-International (FES-I), Participants' fear of falling and confidence in performing daily activities without falling will be assessed using the Falls Efficacy Scale-International (FES-I).

Scale: Scores range from 16 to 64, with higher scores indicating a greater fear of falling (worse outcome)., 9 months|Mobility - Habitual Physical Activity and Real-World Gait, Monitoring participants' habitual physical activity and gait in real-world settings using an Axivity sensor taped to the lower back., 9 months|Mood- Geriatric Depression Scale (GDS, A 15-item questionnaire used to assess depressive symptoms in older adults. Scale: Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms (worse outcome)., 9 months|Mood- SF-36 (Short Form Health Survey), A 36-item questionnaire used to assess overall health-related quality of life, including emotional well-being.

Scale: Scores range from 0 to 100, with higher scores indicating better health and well-being (better outcome)., 9 months|anxiety- Geriatric Anxiety Inventory - Short Form (GAI-SF), Questionnaire: Geriatric Anxiety Inventory - Short Form (GAI-SF). Scores range from 0 to 20, with higher scores indicating greater anxiety (worse outcome)., 9 months|apathy, The Apathy Scale is used to assess the level of apathy in participants. Scale: Scores range from 0 to 42, with higher scores indicating greater apathy (worse outcome)., 9 months|Functional Activity Questionnaire, Functional Activity Questionnaire- Scores range from 0 to 30, with higher scores indicating greater difficulty in performing daily activities (worse outcome)., 9 months|Cognitive Function - Motor Screening Task, Assessment: The Motor Screening Task will evaluate participants' basic motor abilities using a computerized test. Scores range from 0 to 100, with higher scores indicating better motor function., 9 months|Cognitive Function - Reaction Time, Reaction Time will be measured to assess the speed of cognitive processing using a computerized test.

Scale: Reaction time is measured in milliseconds, with lower times indicating faster cognitive processing (better outcome)., 9 months|cognitive Function, battery to minimize procedural learning. ll tests have excellent psychometric properties and normative data suitable for our sample. validated battery of computerized tests (CANTAB Connect Research).Specific tests include the Motor Screening Task, Reaction Time, Paired Associates Learning, Spatial Working Memory, Pattern Recognition Memory, Delayed Matching to Sample, and Rapid Visual Information Processing. Additionally, participants will complete the MoCA, RAVLT, and Category and Phonemic Fluency tests., 9 months|Cognitive Function - Paired Associates Learning, The Paired Associates Learning test will evaluate memory function by assessing participants' ability to recall associations between objects and locations.

Scale: Scores range from 0 to 100, with higher scores indicating better memory function., 9 months|Cognitive Function - Spatial Working Memory, Spatial Working Memory will be assessed using a computerized test to evaluate participants' ability to retain and manipulate spatial information.

Scale: Scores range from 0 to 100, with higher scores indicating better working memory., 9 months|Cognitive Function - Pattern Recognition Memory, Pattern Recognition Memory will be tested to measure participants' visual memory and pattern recognition abilities.

Scale: Scores range from 0 to 100, with higher scores indicating better pattern recognition. Scale: Scores range from 0 to 100, with higher scores indicating better working memory., 9 months|Cognitive Function - Delayed Matching to Sample, Delayed Matching to Sample will be used to evaluate visual memory and matching abilities after a delay.

Scale: Scores range from 0 to 100, with higher scores indicating better matching abilities.

Scale: Scores range from 0 to 100, with higher scores indicating better working memory., 9 months|Cognitive Function - Rapid Visual Information Processing, The Rapid Visual Information Processing task will assess sustained attention and visual processing speed.

Scale: Accuracy is scored from 0 to 100, with higher scores indicating better sustained attention. Reaction time is measured in milliseconds, with lower times indicating faster processing. Scale: Scores range from 0 to 100, with higher scores indicating better working memory., 9 months|Cognitive Function - Montreal Cognitive Assessment (MoCA), The MoCA will be used to evaluate global cognitive function across multiple domains.

Scale: Scores range from 0 to 30, with higher scores indicating better cognitive function., 9 months|Cognitive Function - Rey Auditory Verbal Learning Test (RAVLT), The RAVLT will assess verbal memory through recall and recognition tasks. Scale: Scores range from 0 to 15 for immediate recall, with higher scores indicating better memory performance. Scale: Scores range from 0 to 30, with higher scores indicating better cognitive function., 9 months|Cognitive Function - Category and Phonemic Fluency Tests, These tests will evaluate participants' semantic knowledge and word retrieval abilities.

Scale: Scores represent the number of correct words generated within a time limit, with higher scores indicating better fluency. Scale: Scores range from 0 to 30, with higher scores indicating better cognitive function., 9 months|Height, Height will be measured in meters., 9 months|Weight, Weight will be measured in kilograms., 9 months|Medical History, Medical History, 9 months|Blood Pressure, Blood Pressure, 9 months