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Trial record 1 of 2 for:    NIBS | Canada
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Improving Mobility and Cognition in Older Adults Using Non-Invasive Brain Stimulation (NIBS)

This study is currently recruiting participants.
Verified August 2017 by Manuel Montero Odasso, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02740530
First Posted: April 15, 2016
Last Update Posted: August 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Manuel Montero Odasso, Lawson Health Research Institute
  Purpose
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 Intervention
Executive Dysfunction Gait Performance Repetitive Transcranial Magnetic Stimulation Device: Magstim® Rapid 2 machine

Study Type: Interventional
Study Design: 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

Further study details as provided by Manuel Montero Odasso, Lawson Health Research Institute:

Primary Outcome Measures:
  • Gait velocity - cm/s [ Time Frame: Seven days ]

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

Estimated Enrollment: 40
Study Start Date: April 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
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
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
Canada, Ontario
Parkwood Institute Recruiting
London, Ontario, Canada, N6C 5j1
Contact: Alanna Black, MSc, CCRP    519 685 4292 ext 42179      
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
  More Information

Publications:
Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30. Review.
Montero-Odasso M, Hachinski V. Preludes to brain failure: executive dysfunction and gait disturbances. Neurol Sci. 2014 Apr;35(4):601-4. doi: 10.1007/s10072-013-1613-4. Epub 2013 Dec 24.
Shaw FE. Prevention of falls in older people with dementia. J Neural Transm (Vienna). 2007;114(10):1259-64. Epub 2007 Jun 8. Review.
Oliver D, Connelly JB, Victor CR, Shaw FE, Whitehead A, Genc Y, Vanoli A, Martin FC, Gosney MA. Strategies to prevent falls and fractures in hospitals and care homes and effect of cognitive impairment: systematic review and meta-analyses. BMJ. 2007 Jan 13;334(7584):82. Epub 2006 Dec 8. Review.
Shaw FE, Bond J, Richardson DA, Dawson P, Steen IN, McKeith IG, Kenny RA. Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial. BMJ. 2003 Jan 11;326(7380):73. Erratum in: BMJ. 2003 Mar 29;326(7391):699.
Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-39. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. Review.
Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. Epub 2005 Jul 6.
Luber B, Kinnunen LH, Rakitin BC, Ellsasser R, Stern Y, Lisanby SH. Facilitation of performance in a working memory task with rTMS stimulation of the precuneus: frequency- and time-dependent effects. Brain Res. 2007 Jan 12;1128(1):120-9. Epub 2006 Nov 20.
Barr MS, Farzan F, Rajji TK, Voineskos AN, Blumberger DM, Arenovich T, Fitzgerald PB, Daskalakis ZJ. Can repetitive magnetic stimulation improve cognition in schizophrenia? Pilot data from a randomized controlled trial. Biol Psychiatry. 2013 Mar 15;73(6):510-7. doi: 10.1016/j.biopsych.2012.08.020. Epub 2012 Oct 3.
Doruk D, Gray Z, Bravo GL, Pascual-Leone A, Fregni F. Effects of tDCS on executive function in Parkinson's disease. Neurosci Lett. 2014 Oct 17;582:27-31. doi: 10.1016/j.neulet.2014.08.043. Epub 2014 Aug 30.
Reis J, Robertson EM, Krakauer JW, Rothwell J, Marshall L, Gerloff C, Wassermann EM, Pascual-Leone A, Hummel F, Celnik PA, Classen J, Floel A, Ziemann U, Paulus W, Siebner HR, Born J, Cohen LG. Consensus: Can transcranial direct current stimulation and transcranial magnetic stimulation enhance motor learning and memory formation? Brain Stimul. 2008 Oct;1(4):363-9. doi: 10.1016/j.brs.2008.08.001. Epub 2008 Oct 7. Review.
Elder GJ, Taylor JP. Transcranial magnetic stimulation and transcranial direct current stimulation: treatments for cognitive and neuropsychiatric symptoms in the neurodegenerative dementias? Alzheimers Res Ther. 2014 Nov 10;6(9):74. doi: 10.1186/s13195-014-0074-1. eCollection 2014.
Miniussi C, Cappa SF, Cohen LG, Floel A, Fregni F, Nitsche MA, Oliveri M, Pascual-Leone A, Paulus W, Priori A, Walsh V. Efficacy of repetitive transcranial magnetic stimulation/transcranial direct current stimulation in cognitive neurorehabilitation. Brain Stimul. 2008 Oct;1(4):326-36. doi: 10.1016/j.brs.2008.07.002. Epub 2008 Oct 7. Review.
Pascual-Leone A, Tarazona F, Keenan J, Tormos JM, Hamilton R, Catala MD. Transcranial magnetic stimulation and neuroplasticity. Neuropsychologia. 1999 Feb;37(2):207-17.
Gersner R, Kravetz E, Feil J, Pell G, Zangen A. Long-term effects of repetitive transcranial magnetic stimulation on markers for neuroplasticity: differential outcomes in anesthetized and awake animals. J Neurosci. 2011 May 18;31(20):7521-6. doi: 10.1523/JNEUROSCI.6751-10.2011.
Muir SW, Gopaul K, Montero Odasso MM. The role of cognitive impairment in fall risk among older adults: a systematic review and meta-analysis. Age Ageing. 2012 May;41(3):299-308. doi: 10.1093/ageing/afs012. Epub 2012 Feb 27. Review.
Li KZ, Roudaia E, Lussier M, Bherer L, Leroux A, McKinley PA. Benefits of cognitive dual-task training on balance performance in healthy older adults. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1344-52. doi: 10.1093/gerona/glq151. Epub 2010 Sep 13.
Hausdorff JM, Doniger GM, Springer S, Yogev G, Simon ES, Giladi N. A common cognitive profile in elderly fallers and in patients with Parkinson's disease: the prominence of impaired executive function and attention. Exp Aging Res. 2006 Oct-Dec;32(4):411-29. Erratum in: Exp Aging Res. 2007 Jan-Mar;33(1):121.
Montero-Odasso M, Oteng-Amoako A, Speechley M, Gopaul K, Beauchet O, Annweiler C, Muir-Hunter SW. The motor signature of mild cognitive impairment: results from the gait and brain study. J Gerontol A Biol Sci Med Sci. 2014 Nov;69(11):1415-21. doi: 10.1093/gerona/glu155. Epub 2014 Sep 2.
Muir SW, Speechley M, Wells J, Borrie M, Gopaul K, Montero-Odasso M. Gait assessment in mild cognitive impairment and Alzheimer's disease: the effect of dual-task challenges across the cognitive spectrum. Gait Posture. 2012 Jan;35(1):96-100. doi: 10.1016/j.gaitpost.2011.08.014. Epub 2011 Sep 22.
Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8.

Responsible Party: Manuel Montero Odasso, MD, PhD, FRCPC, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02740530     History of Changes
Other Study ID Numbers: 107526
First Submitted: March 29, 2016
First Posted: April 15, 2016
Last Update Posted: August 24, 2017
Last Verified: August 2017
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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