Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome

N/ANot Yet RecruitingNCT06581458

Tel-Aviv Sourasky Medical Center64 enrolled

Overview

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

* The study aims to investigate the mechanical and neuroplastic effects of a tDCS intervention. * The intervention consists of an initial two-week period of tDCS application, followed by three months of continued tDCS treatment. * A placebo group will receive a dummy treatment for three months to compare the outcomes. * The study will measure various parameters including the costs of performing an action task (dual task cost), walking speed, cognitive measures, and motor function. * A delayed-start design will be used to determine if the effects of tDCS build up over time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Motoric Cognitive Risk Syndrome

Interventions

tDCSDRUG

The immediate intervention group will continue to receive five tDCS treatments per week for 6 months. The late intervention group will receive five sham treatments per week for 3 months and then begin receiving five weekly tDCS treatments for an additional 3 months.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 65-90 * Cognitive complaints * A positive answer to the question "Do you feel you have more problems than most people?" * A negative answer to the question "Is your thinking as clear and sharp as it was before?" * Slow walking - one standard deviation below the average for age and gender (under age 75: men less than 101.9 cm/s, women less than 97.4 cm/s. Over or equal to age 75: men less than 85.3 s) m/s women less than 76.7 cm/s) * No significant disability * There is the ability to walk without support on a walking carpet * A result below 9 in the Functional Activities Questionnaire index * Identification as qualified * Identification as willing and able to operate a tDCS device or have a partner who is able to operate the device during home use. According to the criteria: * Inclusion: selected by the patient, over the age of 21, with basic computer skills and available throughout the study period * Exclusion: MOCA score lower than or equal to 26. Presents insufficient understanding, poor vision, severe joint problems in the hands, deformity pain or other conditions that may interfere with the successful operation of the tDCS * Has access to a reliable wireless internet network (WiFi) at the patient's home Exclusion Criteria: * Less than eight years of study * dementia * According to the clinical definition clinical dementia rationing (CDR) score 1 or higher * Previous diagnosis * Performance in the range indicating dementia in the neuropsychological test bettery (lower than 2 standard deviations below the age- and sex-matched average) * IQ is low or equal to 85 in the WTAR test. without a background of mental disability * Current diagnosis of major psychiatric disorders (schizophrenia, bipolar, major depression) * Evidence of moderate to severe symptoms of depression. A score high or equal to 9 on the 15 item geriatric depression scale * History of head injury that led to prolonged loss of consciousness * History of palpitations of unknown origin that may indicate convulsions * History of convulsions, diagnosis of epilepsy in the patient or in most of the first degree family. Except for a case of a single seizure of benign etiology determined by a neurologist * Hospitalization during the last three months following an acute illness or musculoskeletal injury with a significant impact on walking or stability * An unbalanced medical condition that can worsen following convulsive stimulation (cardiac malformation, cardiac arrhythmias, asthma, etc.) * Substance use disorders during the last six months * A wig or hair design that prevents contact of the electrodes with the scalp or interferes with the administration of the stimulation * Chronic vertigo * A cardiac event within the last six months * Active cancer treated with chemotherapy or radiation * blindness * Visual hallucinations (according to history or self-report) * There are contraindications for MRI or tDCS as defined by the International Federation for Clinical Neurophysiology * Includes unprovoked convulsions during the last 2 years * Danger of finding ferromagnetic objects in the body, self-reporting of medical implants in the body (DBS, deep brain stimulation, drug delivery pump, cochlear implant, pacemaker) * Inventions active dermatological condition * History of behavior disorders in REM sleep, sometimes an early sign of Parkinson's disease * Medications and medical history will be examined by a clinician and a decision regarding entry into the study will be based on medical history, current medication dosage and medication change before or during the treatment as well as combination with other active CNS medications.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 45-second

Secondary Outcomes

Mobility - SPPB (Short Physical Performance Battery)

Evaluating participants' physical performance through a battery of tests including balance, walking speed, and chair stand tests.

Time frame: 9 months

Mobility - 4 m Gait Test

Measuring participants' gait speed over a 4-meter distance.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 9 months

Height

Height will be measured in meters.

Time frame: 9 months

Weight

Weight will be measured in kilograms.

Time frame: 9 months

Medical History

Time frame: 9 months

Blood Pressure

Time frame: 9 months