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Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT01897025
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborators:
National University Health System, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:

Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment.

Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus).

In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS).

We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI).

This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.


Condition or disease Intervention/treatment Phase
Stroke Device: real-tDCS with MI-BCI Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
Study Start Date : January 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: real-tDCS with MI-BCI

10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.

Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.

After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.

Device: real-tDCS with MI-BCI
As in Arm Description

Sham Comparator: sham-tDCS with MI-BCI

10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:

The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.

MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.

Device: real-tDCS with MI-BCI
As in Arm Description




Primary Outcome Measures :
  1. Upper Extremity Component of Fugl-Meyer Assessment [ Time Frame: week 0, week 2, week 4 ]
    The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).


Secondary Outcome Measures :
  1. Resting Motor Threshold of Stroke Affected M1 Motor Cortex [ Time Frame: pre- and post-training, 4 weeks post-training ]

    Resting motor threshold (RMT) is defined as the percentage of maximum stimulator output required to elicit motor evoked potential (MEP) with 50 µV peak-to-peak amplitude in at least 4 out of 8 trials during single-pulse transcranial magnetic stimulation (TMS).

    Short intra-cortical inhibition (SICI) and intracortical facilitation (ICF) were measured using paired pulse stimulation with an initial conditioning stimulus of 80% of RMT and a test stimulus of 120% of RMT. MEPs were recorded at inter-stimulus intervals (ISIs) of 2, 4, 6, 10 and 15 ms. ISIs of 1-3 ms typically induce SICI while ISIs of 10-15ms typically reflect ICF.

    This part of data is still under analyzing.


  2. Grip Strength [ Time Frame: pre- and post-training, and again at 4 weeks post-training ]
    Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.

  3. Box and Block Test [ Time Frame: pre and post training, and 4 weeks post training ]
    Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.

  4. MRI Parameters [ Time Frame: -2, 0 and 4 weeks ]
    active and passive fMRI, DTI, This part of data is still under analyzing.



Information from the National Library of Medicine

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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:

  • first ever haemorrhagic or ischaemic subcortical stroke more than 9 months prior to study enrollment
  • upper extremity impairment of 11-45 on the Fugl-Meyer assessment scale

Exclusion Criteria:

  • epilepsy
  • neglect
  • cognitive impairment
  • other neurological or psychiatric diseases
  • severe arm pain
  • spasticity score >2 on the Modified Ashworth Scale in the shoulder or elbow
  • contraindications to TMS or tDCS (cranial implants, ventricular shunts, pacemakers, intrathecal pumps)
  • grip strength <10kg as measured by a dynamometer
  • participation in other interventions or trials targeting stroke motor recovery.

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): NCT01897025


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, MBBS National University Hospital, Singapore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01897025     History of Changes
Other Study ID Numbers: NIG09may022
First Posted: July 11, 2013    Key Record Dates
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016
Last Verified: February 2016

Keywords provided by National University Hospital, Singapore:
Stroke
Noninvasive brain stimulation
Brain-computer interface
Motor imagery
Rehabilitation

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