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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02740530
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
71
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Magstim® Rapid 2 machine
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain Stimulation
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: rTMS Active

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
See Arms description
Other Names:
  • MAGSTIM® RAPID II SYSTEM License number 69773

    		•
    Placebo Comparator: rTMS Sham

    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
    Other Names:
  • MAGSTIM® RAPID II SYSTEM License number 69773

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Gait velocity - cm/s [Seven days]

    Secondary Outcome Measures

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

    Other Outcome Measures

    1. Gait variability which is calculated as coefficient of variation (CoV) [Seven days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parkwood Institute London Ontario Canada

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Manuel Montero Odasso, MD,PhD, Lawson Health Research Institute, Western University, St. Joseph's Healthcare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Manuel Montero Odasso, MD, PhD, FRCPC, Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02740530
    Other Study ID Numbers:
    • 107526
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 28, 2020