Clinical trial NCT06581458: Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
Official title: Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motoric Cognitive Risk Syndrome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-09-03
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy in Serial Subtractions Task
timeFrame: 45-second
measure: Usual walk
timeFrame: 45-second
measure: Walk with the cognitive task (DT)
timeFrame: 45-second
Secondary outcomes:
measure: Mobility - SPPB (Short Physical Performance Battery)
timeFrame: 9 months
measure: Mobility - 4 m Gait Test
timeFrame: 9 months
measure: Mobility - Falls Efficacy Scale-International (FES-I)
timeFrame: 9 months
measure: Mobility - Habitual Physical Activity and Real-World Gait
timeFrame: 9 months
measure: Mood- Geriatric Depression Scale (GDS
timeFrame: 9 months
measure: Mood- SF-36 (Short Form Health Survey)
timeFrame: 9 months
measure: anxiety- Geriatric Anxiety Inventory - Short Form (GAI-SF)
timeFrame: 9 months
measure: apathy
timeFrame: 9 months
measure: Functional Activity Questionnaire
timeFrame: 9 months
measure: Cognitive Function - Motor Screening Task
timeFrame: 9 months
measure: Cognitive Function - Reaction Time
timeFrame: 9 months
measure: cognitive Function
timeFrame: 9 months
measure: Cognitive Function - Paired Associates Learning
timeFrame: 9 months
measure: Cognitive Function - Spatial Working Memory
timeFrame: 9 months
measure: Cognitive Function - Pattern Recognition Memory
timeFrame: 9 months
measure: Cognitive Function - Delayed Matching to Sample
timeFrame: 9 months
measure: Cognitive Function - Rapid Visual Information Processing
timeFrame: 9 months
measure: Cognitive Function - Montreal Cognitive Assessment (MoCA)
timeFrame: 9 months
measure: Cognitive Function - Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 9 months
measure: Cognitive Function - Category and Phonemic Fluency Tests
timeFrame: 9 months
measure: Height
timeFrame: 9 months
measure: Weight
timeFrame: 9 months
measure: Medical History
timeFrame: 9 months
measure: Blood Pressure
timeFrame: 9 months
Other outcomes:
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