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Effect of Brain-Computer Interfaced-Assisted Motor Imagery for Gait Retraining in Stroke Patients

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ClinicalTrials.gov Identifier: NCT02507895
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
National University Health System, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:

Currently the process for stroke recovery is slow with majority of its treatments focused around physical therapy. Among the many methods employed to facilitate recovery in stroke, the use of motor imagery (MI) training may be beneficial towards stroke rehabilitation.

In the current study, we propose 2 aims. Our first aim is to determine the feasibility and efficacy of a novel brain-computer interface-assisted MI train program (BCI-MI) in patients with chronic ischemic stroke. This is designed as a proof-of-concept study that only require a single-session trial. If patients successfully activate the BCI-MI system without much difficulty, our second aim is to enroll patients into a 4-week training program using the BCI-MI. Both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) will be done to determine the effects of the 4-week training program. Subjects may potentially see improvements in walking gait as preliminary data from previous studies have demonstrated positive results.


Condition or disease Intervention/treatment Phase
Stroke Device: MI-BCI Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain-Computer Interface-Assisted Motor Imagery for Gait Retraining in Neurorehabilitation
Study Start Date : October 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: MI-BCI training
subjects will undergo 12 sessions over 4 weeks of MI-BCI training
Device: MI-BCI
Subjects will be seated comfortably in front of a computer screen. An EEG cap will be comfortably worn over the head of the subject to record EEG traces of any activated cortical areas. If subjects are able to activate the device and are agreeable to participate in the second phase of the study, they will be enrolled in a 4-week BCI-MI training program of 12 sessions. Subjects will be required to perform 160 trials of MI altogether with assigned rest periods (5 mins) every 40 trials. Each session will last approximate 45 minutes excluding set up time.




Primary Outcome Measures :
  1. changes of " gait parameters measured by " from baseline to post-training and 4-6 weeks after training [ Time Frame: baseline, 5 min after training, 4-6 weeks after training ]
    Gait analysis will be performed using the Tekscan walkway system. Subjects will be required to walk on a mat at their comfort speed. Gait parameters including step and stride parameters, symmetry scores, velocity, and cadence temporal will be collected and recorded while the subject is walk along the walkway.


Secondary Outcome Measures :
  1. Changes of "cortical excitability measured by TMS" from baseline to post-training and 4-6 weeks after training [ Time Frame: baseline, 5 min after training, 4-6 weeks after training ]
    Motor threshold will be measured according to the technique described by Rossini et al. (1994). For the MEP study, we will initially adjust TMS intensity to achieve a baseline MEP in the tibialis anterior muscle of the leg to about 1 mV peak-to-peak amplitude before intervention. Stimulation intensity will be kept constant for each subject throughout the study. We will record 10 MEPs for each time and average their peak-to-peak amplitude and area under-the-curve. For the paired-pulse stimulation, a first subthreshold conditioning stimulus will be applied, followed at a variable interstimulus interval (ISI), by a second suprathreshold stimulus. We will use the following ISIs - 2, 3, 4, 6, 9, 10, 12, 15 ms. The percentage of change for each ISI before and after treatment will be calculated from the MEPs and will therefore important to measure changes in intracortical facilitation and inhibition. Each session will last approximate 1 hour including set-up time.

  2. changes of " cortical excitability measured by fMRI/DTI" from baseline to post-training and 4-6 weeks after training [ Time Frame: baseline, 5 min after training, 4-6 weeks after training ]
    All subjects will be asked to make their way on their own to CIRC, NUS. The patients are currently treated in an outpatient setting and their condition is stable. A research assistant will be onsite to meet the patient at CIRC and run through the whole procedure with the patient. Prior to the scan, all patients will be briefed of the test procedure and safety aspects. A medically-trained physician will be on standby throughout the procedure. All participants will be scanned on a 3-T GE scanner using a standard radiofrequency head coil. Head motion was minimized by foam padding and forehead-restraining straps. A T1-weighted high-resolution scan and a set of axial fluid attenuated inversion recovery images will be acquired. T1-weighted and fluid-attenuated inversion recovery images will be realigned and spatially normalized into images of isotropic voxel size implemented in Matlab. Each session will last approximate 1 hour including set-up time.

  3. Mobility changes from baseline to post-training and 4-6 weeks after training, as measured by "timed up-and-go test" [ Time Frame: baseline, 5 min after training, 4-6 weeks after training ]
    The timed up-and-go test is a measurement of mobility. It includes a number of tasks such as standing from a seating position, walking, turning, stopping, and sitting down. For the test, the person is asked to stand up from a standard chair and walk a distance of approximately 3 meters, turn around and walk back to the chair and sit down again.

  4. changes of walking speed measured by "10 metre walk test", from baseline to post-training and 4-6 weeks after training [ Time Frame: baseline, 5 min after training, 4-6 weeks after training ]
    The 10 meter walk test is a test of walking speed.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 21-70 years;
  • first ever haemorrhagic or ischaemic hemiplegic stroke more than 9 months prior to study enrollment;
  • Functional Ambulatory Category 3-4 (requires not more than minimal assistance for walking)

Exclusion Criteria:

  • Severe claustrophobia;
  • pregnancy;
  • cardiac pacemakers;
  • orthodontics (braces);
  • metal implant;
  • presence of other non MR-compatible ferromagnetic implants;
  • history of epilepsy;
  • sensorimotor disturbance due to other causes other than stroke;
  • severe pain in the lower limbs affecting gait;
  • uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
  • major depression and a history of psychotic disorders.

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): NCT02507895


Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University Health System, Singapore
Agency for Science, Technology and Research
Investigators
Principal Investigator: Effie Chew, MD National University Hospital, Singapore

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02507895     History of Changes
Other Study ID Numbers: BCI-LL2012/00658
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: November 2017

Keywords provided by National University Hospital, Singapore:
Stroke
lower extremeties
Brain-computer interface
Motor imagery
Rehabilitation
TMS

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases