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Trial record 1 of 8 for:    NIBS | Canada
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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 : Unknown
Verified February 2020 by Manuel Montero Odasso, Lawson Health Research Institute.
Recruitment status was:  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

Study Description
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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
Executive Dysfunction Gait Performance Repetitive Transcranial Magnetic Stimulation Device: Magstim® Rapid 2 machine Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
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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 Name: 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 Name: MAGSTIM® RAPID II SYSTEM License number 69773


Outcome Measures
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Primary Outcome Measures :
  1. Gait velocity - cm/s [ Time Frame: 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. [ Time Frame: seven days ]

Other Outcome Measures:
  1. Gait variability which is calculated as coefficient of variation (CoV) [ Time Frame: Seven days ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740530


Contacts
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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

Locations
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Canada, Ontario
Parkwood Institute Recruiting
London, Ontario, Canada
Contact: Manuel Montero-Odasso         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Manuel Montero Odasso, MD,PhD Lawson Health Research Institute, Western University, St. Joseph's Healthcare
More Information
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Publications:

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Responsible Party: Manuel Montero Odasso, MD, PhD, FRCPC, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02740530    
Other Study ID Numbers: 107526
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No