Home Transcranial Direct-Current Stimulation for Motoric Cognitive Risk Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorTel-Aviv Sourasky Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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?"

Disqualifiers

Less than eight years of study

dementia

According to the clinical definition clinical dementia rationing (CDR) score 1 or higher

Previous diagnosis

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: tDCS immediate intervention groupExperimental treatment 1 intervention
Group B: Late intervention group (tDCS+ sham)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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
2

Mobility - 4 m Gait Test

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

Time frame
9 months
3

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
4

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.

Time frame
9 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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