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

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ClinicalTrials.gov Identifier: NCT02740530
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Montero Odasso, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 15, 2016
Last Update Posted Date February 28, 2020
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Gait velocity - cm/s [ Time Frame: Seven days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds. [ Time Frame: seven days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 14, 2016)
Gait variability which is calculated as coefficient of variation (CoV) [ Time Frame: Seven days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation
Official Title  ICMJE Improving Mobility and Cognition in Older Adults: Establishment of an Interdisciplinary Clinical Research Program Using Non-Invasive Brain 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Executive Dysfunction
  • Gait Performance
  • Repetitive Transcranial Magnetic Stimulation
Intervention  ICMJE Device: Magstim® Rapid 2 machine
See Arms description
Other Name: MAGSTIM® RAPID II SYSTEM License number 69773
Study Arms  ICMJE
  • 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.
    Intervention: Device: Magstim® Rapid 2 machine
  • 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
    Intervention: Device: Magstim® Rapid 2 machine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Manuel Montero Odasso, MD, PhD 519-685-4292 ext 42369 Manuel.MonteroOdasso@sjhc.london.on.ca
Contact: Amer Burhan, MBChB, FRCPC 519-685-4292 ext 47326 Amer.Burhan@sjhc.london.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02740530
Other Study ID Numbers  ICMJE 107526
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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
Responsible Party Manuel Montero Odasso, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Montero Odasso, MD,PhD Lawson Health Research Institute, Western University, St. Joseph's Healthcare
PRS Account Lawson Health Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP