Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome

NCT06581458 | Not Yet Recruiting

• 1 other identifier: 0098-24-TLV
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 3.Examining mechanical and neuroplastic effects of tDCS intervention
4. 4.To examine the response to tDCS over time

Conditions

Motoric Cognitive Risk Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Mobility - SPPB (Short Physical Performance Battery)

  9 months

• Mobility - 4 m Gait Test

  9 months

• Mobility - Falls Efficacy Scale-International (FES-I)

  9 months

• Mobility - Habitual Physical Activity and Real-World Gait

  9 months

• Mood- Geriatric Depression Scale (GDS

  9 months

Study Arms (2)

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.

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.

Drug: tDCS

Interventions

tDCS DRUG

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.

Late intervention group (tDCS+ sham); tDCS immediate intervention group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Has access to a reliable wireless internet network (WiFi) at the patient's home
• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share