Clinical trial NCT02740530: Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation
Official title: Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Executive Dysfunction
Gait Performance
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria:

* Persons with metal anywhere in the head, excluding the mouth, including shrapnel, and screws and clips from surgical procedures
* Persons with cardiac pacemakers, implanted medication pumps, electrodes inside the heart
* Unstable heart disease
* Persons with increased intracranial pressure, as in acute large infarctions or trauma
* Previous major stroke, history seizure, Parkinson D, Huntington D.
* History of schizophrenia/schizo-affective disorder, substance use disorder within 1 year of study

Primary outcomes:
measure: Gait velocity - cm/s
timeFrame: Seven days
Secondary outcomes:
measure: Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.
timeFrame: seven days
Other outcomes:
measure: Gait variability which is calculated as coefficient of variation (CoV)
timeFrame: Seven days
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: Lawson Health Research Institute, Western University, St. Joseph's Healthcare
name: Manuel Montero Odasso, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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