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

NCT02740530 | Terminated

• 1 other identifier: 107526
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Dysfunction; Gait Performance; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Gait velocity - cm/s

  Seven days

Secondary Outcomes (1)

• Executive function, assessed as time to take to complete Trail Making A and B (TMT A and B) in seconds.

  seven days

Other Outcomes (1)

• Gait variability which is calculated as coefficient of variation (CoV)

  Seven days

Study Arms (2)

rTMS Active

EXPERIMENTAL

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

rTMS Sham

PLACEBO COMPARATOR

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

Interventions

Magstim® Rapid 2 machine DEVICE

See Arms description

Also known as: MAGSTIM® RAPID II SYSTEM License number 69773

rTMS Active; rTMS Sham

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Parkwood Institute

London, Ontario, Canada

Location

Related Publications (23)

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Study Officials

• Manuel Montero Odasso, MD,PhD

  Lawson Health Research Institute, Western University, St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)