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

Not Applicable

Terminated

• Conditions: Gait Performance; Executive Dysfunction; Repetitive Transcranial Magnetic Stimulation
• Interventions: Device: Magstim® Rapid 2 machine

• Registration Number: NCT02740530
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-29
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Primary Completion: 2022-03
• Study Completion: 2023-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS Active	Magstim® Rapid 2 machine	High frequency pulsed repetitive magnetic stimulation at 100 % resting motor threshold will be delivered using a figure of 8 air film cooled coil attached to the Magstim® Rapid 2 machine. Resting motor threshold will be determined minimum energy needed to elicit the a reliable visible contraction in the contra-lateral first interosseous muscle using single pulse rTMS applied to the area between C1-C3 using the 10-20 international EEG electrode system. For stimulation, the coil will be positioned on the scalp corresponding to F4 then F3 electrode position using the 10-20 international EEG system. Real stimulation will consist of delivering 1200 pulses at 20 hz frequency to F4 location followed by the same stimulation to F3. The total time needed to deliver pulses is 20 minutes.
rTMS Sham	Magstim® Rapid 2 machine	Sham stimulation will also involve delivering the same stimulus but with angulation of the coil at 45 degrees, which will give similar scalp sensation but unlikely to deliver magnetic stimulation to the cortex

Primary Outcome Measures

Name	Time	Method
Gait velocity - cm/s	Seven days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Parkwood Institute; 🇨🇦 London, Ontario, Canada