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Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation

Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740530
Acronym
NIBS
Enrollment
25
Registered
2016-04-15
Start date
2016-04-30
Completion date
2023-05-31
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Executive Dysfunction, Gait Performance, Repetitive Transcranial Magnetic Stimulation

Brief summary

This study aims to test the efficacy of a type of non-invasive brain stimulation (NIBS), known as repetitive transcranial magnetic (rTMS) stimulation, in improving mobility, particularly gait stability and variability, and executive dysfunction in older adults. The study will be conducted in forty older adults (≥60 years) with a diagnosis of executive dysfunction.

Detailed description

The proposed study using rTMS will build upon the investigators previous work demonstrating the link between cognitive impairment, particularly executive dysfunction, and mobility/gait abnormalities in older adults, even in those labeled as cognitively normal. Emerging evidence demonstrates that executive dysfunction is an early phenomenon in the pathway to mobility disability and subtle changes in executive function are independently associated with future falls. The investigators have piloted studies showing that pharmacological enhancement of executive function, can improve gait-motor performance and, potentially, reduce mobility decline and risk of falls. This supports the rationale for a promising intervention: enhancing cognition to prevent mobility decline and reduce risk of falls. The long-term goal is to create a clinical research program to apply rTMS as an early novel intervention for cognitive/motor interaction to ultimately delay the onset of cognitive and mobility disabilities and their devastating consequences, dementia and falls, in older adults. However, it is first necessary to study a smaller group of seniors to plan for recruitment, study retention and compliance, and to gather preliminary data as proof of principle before proceeding to a larger clinical trial.

Interventions

DEVICEMagstim® Rapid 2 machine

See Arms description

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Having executive dysfunction (defined as score below 11 out of a possible 13 in the Montreal Cognitive Assessment -MoCA- executive score index) * Age 60 years and older * English speaking * Able to ambulate 10m independently without any gait aid (eg. walker, cane)

Exclusion criteria

* Unable to understand or communicate in English * Parkinsonism or any neurological disorder with residual motor deficit (eg. Major stroke, epilepsy) * Musculoskeletal disorder detected by clinical examination which affects gait performance -Active osteoarthritis affecting lower limbs (American College of Rheumatology criteria) * Severe depression operationalized as Geriatric Depression Scale (GDS) score\>10 TMS specific

Design outcomes

Primary

MeasureTime frame
Gait velocity - cm/sSeven days

Secondary

MeasureTime frame
Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.seven days

Other

MeasureTime frame
Gait variability which is calculated as coefficient of variation (CoV)Seven days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026