Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu
Trial record 1 of 8 for:    NIBS | Canada
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Manuel Montero Odasso, 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.

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.

Layout table for study information
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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT02740530

Layout table for location contacts
Contact: Manuel Montero Odasso, MD, PhD 519-685-4292 ext 42369
Contact: Amer Burhan, MBChB, FRCPC 519-685-4292 ext 47326

Layout table for location information
Canada, Ontario
Parkwood Institute Recruiting
London, Ontario, Canada
Contact: Manuel Montero-Odasso         
Sponsors and Collaborators
Lawson Health Research Institute
Layout table for investigator information
Principal Investigator: Manuel Montero Odasso, MD,PhD Lawson Health Research Institute, Western University, St. Joseph's Healthcare

Layout table for additonal information
Responsible Party: Manuel Montero Odasso, MD, PhD, FRCPC, Lawson Health Research Institute 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No