An interventional study of Magstim® Rapid 2 machine in Executive Dysfunction, Gait Performance and Repetitive Transcranial Magnetic Stimulation, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Terminated at 1 site in Canada. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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.
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.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TMS specific exclusion criteria:
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.
Device: 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
Device: Magstim® Rapid 2 machine
See Arms description
Also known as: MAGSTIM® RAPID II SYSTEM License number 69773
Gait velocity - cm/s
Time frame: Seven days
Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.
Time frame: seven days
Gait variability which is calculated as coefficient of variation (CoV)
Time frame: Seven days
Plan to share: No — Due to the proof of principle nature of this study, our data will be crucial to establish efficacy of the intervention and furhet apply for funding for larger, clinical trial to test efectiveness
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's