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

NCT02507895 | Completed DMC

• 1 other identifier: BCI-LL2012/00658
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; lower extremeties; Brain-computer interface; Motor imagery; Rehabilitation; TMS

Outcome Measures

Primary Outcomes (1)

• changes of " gait parameters measured by " from baseline to post-training and 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.

  baseline, 5 min after training, 4-6 weeks after training

Secondary Outcomes (4)

• Changes of "cortical excitability measured by TMS" from baseline to post-training and 4-6 weeks after training

  baseline, 5 min after training, 4-6 weeks after training

• changes of " cortical excitability measured by fMRI/DTI" from baseline to post-training and 4-6 weeks after training

  baseline, 5 min after training, 4-6 weeks after training

• Mobility changes from baseline to post-training and 4-6 weeks after training, as measured by "timed up-and-go test"

  baseline, 5 min after training, 4-6 weeks after training

• changes of walking speed measured by "10 metre walk test", from baseline to post-training and 4-6 weeks after training

  baseline, 5 min after training, 4-6 weeks after training

Study Arms (1)

MI-BCI training

EXPERIMENTAL

subjects will undergo 12 sessions over 4 weeks of MI-BCI training

Device: MI-BCI

Interventions

MI-BCI DEVICE

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.

MI-BCI training

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University Health System, Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

• Dunsky A, Dickstein R, Ariav C, Deutsch J, Marcovitz E. Motor imagery practice in gait rehabilitation of chronic post-stroke hemiparesis: four case studies. Int J Rehabil Res. 2006 Dec;29(4):351-6. doi: 10.1097/MRR.0b013e328010f559.

  PMID: 17106356 BACKGROUND

• Dunsky A, Dickstein R, Marcovitz E, Levy S, Deutsch JE. Home-based motor imagery training for gait rehabilitation of people with chronic poststroke hemiparesis. Arch Phys Med Rehabil. 2008 Aug;89(8):1580-8. doi: 10.1016/j.apmr.2007.12.039.

  PMID: 18674992 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Effie Chew, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: July 24, 2015
• Study Start: October 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2017-11

Locations

SG (1)