Transcranial Direct Current Stimulation for Dementia

(TDCS4MCR Trial)

Recruiting at1 trial location

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hebrew SeniorLife

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in older adults with motoric cognitive risk syndrome (MCR).

Research Team

Eligibility Criteria

This trial is for older adults with motoric cognitive risk syndrome (MCR), which often includes issues with memory and movement. Participants should be experiencing early signs of cognitive decline and mobility disability but specifics on inclusion criteria are not provided.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score ≥21

Access to reliable WiFi in the participant's home

Identification of an eligible informant

Exclusion Criteria

Formal education less than the 8th grade

Any current diagnosis of a major psychiatric disorder

Presence of dementia as defined by a Clinical Dementia Rating (CDR) scale of 1 or higher, previous physician diagnosis of dementia, or performance on the proposed neuropsychological test battery in the dementia range

Treatment Details

Interventions

• Personalized Transcranial Direct Current Stimulation (tDCS) (Behavioural Intervention)

Trial Overview The study tests a home-based brain stimulation technique called personalized transcranial direct current stimulation (tDCS) targeting the brain's left dorsolateral prefrontal cortex over six months, to see if it improves thinking skills and mobility in MCR patients.

Participant Groups

Group I: Personalized Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive 5 weekly home-based tDCS sessions for 6 months. Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.

Group II: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS) Active Control 2 Interventions

After an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period.

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Tel Aviv Medical Center

Collaborator

Trials

29

Recruited

8,100+