Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Neuroscience Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Institue for Infocomm Research, A*Star
Information provided by:
National Neuroscience Institute
ClinicalTrials.gov Identifier:
NCT00955838
First received: August 6, 2009
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.


Condition Intervention
Stroke
Other: Rehabilitation technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke

Resource links provided by NLM:


Further study details as provided by National Neuroscience Institute:

Primary Outcome Measures:
  • Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition [ Time Frame: Baseline (0 months), 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Fugly Meyer motor score for upper limb (0-66) [ Time Frame: Baseline (0 months), 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Motor Assessment Scale [ Time Frame: Baseline (0 months), 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional assessments [ Time Frame: Baseline (0 months), 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
  • Neuroradiological parameters [ Time Frame: Baseline (0 months), 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manus Other: Rehabilitation technique
12 therapy session
Other Name: Stroke Rehabilitation technique
Experimental: BCI_Manus Other: Rehabilitation technique
12 therapy session
Other Name: Stroke Rehabilitation technique

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic).
  2. Moderate to severe upper extremity (UE) weakness post stroke.
  3. Fugly-Meyer motor score of the upper limb < 40.
  4. Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region.
  5. Able to give own consent and understand simple instructions and learn through practice.
  6. Resting brain states determined by FMRI criteria

Exclusion Criteria:

  1. Recurrent stroke.
  2. Previous brain surgery.
  3. Spasticity of Modified Ashworth scale > 2.
  4. Fixed contracture of any upper limb joint
  5. Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy
  6. Upper limb pain or painful joints in upper limb.
  7. Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training.
  8. . History of seizures in the past 12 months.
  9. Severe left neglect
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955838

Contacts
Contact: Sui Geok, Karen Chua, MD +(65)64506164 Karen_Chua@ttsh.com.sg

Locations
Singapore
National Neuroscience Institute Recruiting
Singapore, Singapore, 308433
Contact: Beng Ti, Christopher Ang, MD    +65 63577191    beng_ti_ang@nni.com.sg   
Principal Investigator: Beng Ti, Christopher Ang, MD         
Sponsors and Collaborators
National Neuroscience Institute
Tan Tock Seng Hospital
Institue for Infocomm Research, A*Star
Investigators
Principal Investigator: Beng Ti, Christopher Ang, MD National Neuroscience Institute
  More Information

No publications provided

Responsible Party: Christopher Beng Ti, ANG, National Neuroscience Institute
ClinicalTrials.gov Identifier: NCT00955838     History of Changes
Other Study ID Numbers: BCIStroke
Study First Received: August 6, 2009
Last Updated: August 7, 2009
Health Authority: Singapore: Domain Specific Review Boards

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

ClinicalTrials.gov processed this record on August 21, 2014