Motoric Cognitive Risk SyndromeHometDCSNCT06581458
Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
A study testing tDCS in people with Motoric Cognitive Risk Syndrome, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Motoric Cognitive Risk Syndrome
- What is being tested?
- tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
- 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.
- To examine whether the effects of tDCS build up over time by creating a delayed start mechanism in the intervention (delayed-start design)
- Examining mechanical and neuroplastic effects of tDCS intervention
- To examine the response to tDCS over time
Read the detailed description
- 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.
- Conditions
- Motoric Cognitive Risk Syndrome
- Being tested
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS immediate intervention group | Experimental | Participants in the tDCS Immediate Intervention Group will receive an initial two-week period of transcranial Direct Current Stimulation (tDCS) treatment. This will be followed by three months of continued tDCS intervention. Receives: Drug: tDCS |
| Late intervention group (tDCS+ sham) | Sham comparator | Participants in the Late Intervention Group will first receive a placebo (sham) treatment for three months. This will be followed by a two-week period of active transcranial Direct Current Stimulation (tDCS) treatment, then three months of continued tDCS intervention. Receives: Drug: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 45-second
Secondary outcomes (24)
Mobility - SPPB (Short Physical Performance Battery)
Evaluating participants' physical performance through a battery of tests including balance, walking speed, and chair stand tests.
Measured: 9 months
Mobility - 4 m Gait Test
Measuring participants' gait speed over a 4-meter distance.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Height
Height will be measured in meters.
Measured: 9 months
Weight
Weight will be measured in kilograms.
Measured: 9 months
Medical History
Medical History
Measured: 9 months
Blood Pressure
Blood Pressure
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motoric Cognitive Risk SyndromeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581458
- Sponsor's protocol ID
- 0098-24-TLV
- Acronym
- HometDCS
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
- ClinicalTrials.gov ID
- NCT06581458
- Acronym / sponsor ID
- HometDCS / 0098-24-TLV
- Conditions
- Motoric Cognitive Risk Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Sep 2024 (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.
- 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.
- To examine whether the effects of tDCS build up over time by creating a delayed start mechanism in the intervention (delayed-start design)
- Examining mechanical and neuroplastic effects of tDCS intervention
- To examine the response to tDCS over time
Detailed description
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS immediate intervention group | Experimental | Drug: tDCSParticipants in the tDCS Immediate Intervention Group will receive an initial two-week period of transcranial Direct Current Stimulation (tDCS) treatment. This will be followed by three months of continued tDCS intervention. |
| Late intervention group (tDCS+ sham) | Sham comparator | Drug: tDCSParticipants in the Late Intervention Group will first receive a placebo (sham) treatment for three months. This will be followed by a two-week period of active transcranial Direct Current Stimulation (tDCS) treatment, then three months of continued tDCS intervention. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age 65-90
- Cognitive complaints
- 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
- Identification as qualified
Key exclusion criteria (26 listed)
- Less than eight years of study
- dementia
- 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
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 |
|---|---|---|
| tDCSThe 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. | Drug | Late intervention group (tDCS+ sham), tDCS immediate intervention group |
Primary outcome
Accuracy in Serial Subtractions Task
Time frame: 45-second
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.
Usual walk
Time frame: 45-second
fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle.
Walk with the cognitive task (DT)
Time frame: 45-second
fNIRS with walking trial 20m indoor course with 180-degree turns at each end and an instrumented gait mat in the middle.
24 secondary outcomes
Mobility - SPPB (Short Physical Performance Battery)
Time frame: 9 months
Mobility - 4 m Gait Test
Time frame: 9 months
Mobility - Falls Efficacy Scale-International (FES-I)
Time frame: 9 months
Mobility - Habitual Physical Activity and Real-World Gait
Time frame: 9 months
Mood- Geriatric Depression Scale (GDS
Time frame: 9 months
Mood- SF-36 (Short Form Health Survey)
Time frame: 9 months
anxiety- Geriatric Anxiety Inventory - Short Form (GAI-SF)
Time frame: 9 months
apathy
Time frame: 9 months
Functional Activity Questionnaire
Time frame: 9 months
Cognitive Function - Motor Screening Task
Time frame: 9 months
Cognitive Function - Reaction Time
Time frame: 9 months
cognitive Function
Time frame: 9 months
Cognitive Function - Paired Associates Learning
Time frame: 9 months
Cognitive Function - Spatial Working Memory
Time frame: 9 months
Cognitive Function - Pattern Recognition Memory
Time frame: 9 months
Cognitive Function - Delayed Matching to Sample
Time frame: 9 months
Cognitive Function - Rapid Visual Information Processing
Time frame: 9 months
Cognitive Function - Montreal Cognitive Assessment (MoCA)
Time frame: 9 months
Cognitive Function - Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 9 months
Cognitive Function - Category and Phonemic Fluency Tests
Time frame: 9 months
Height
Time frame: 9 months
Weight
Time frame: 9 months
Medical History
Time frame: 9 months
Blood Pressure
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Motoric Cognitive Risk Syndrome, run by Tel-Aviv Sourasky Medical Center.
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 13 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in Serial Subtractions Task (time frame: 45-second). The study lists 3 primary outcomes in all. 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 3 Sep 2024.