StrokePhase 2NCT01897025
Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation
A Phase 2 study testing real-tDCS with MI-BCI in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- real-tDCS with MI-BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2011to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
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).
Read more
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.
Read the detailed description
This is a randomised controlled trial of 32 subjects who have sustained their first ever subcortical stroke more than 9 months prior to study enrollment, with upper extremity impairment of 11-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale.
Subjects will be randomly allocated to one of the following 2 groups by using a computer-generated random sequence:
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of tDCS preceding training.
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of sham-tDCS preceding training. tDCS-BCI protocol Each of the 10 sessions of tDCS-BCI or sham-BCI will be conducted as follows: tDCS will be performed for 20 minutes immediately prior to each session of motor training. The anode will be placed over the M1 motor cortex of the affected hemisphere while the cathode will be placed over the unaffected M1.
After initial calibration, MI-BCI training will involve MI 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 and will be undertaken by a research assistant blinded to the condition of tDCS.
Outcome measures Improvement in motor functional ability will be the main outcome of this study. Outcome measures will be assessed at the following time points: prior to treatment initiation, at week 2 (immediate post-training period) and week 6 (4 weeks after completion of training). A clinician blinded to the treatment condition will assess the effects of the intervention. Our primary outcome measure will be the upper extremity score of the Fugl-Meyer Assessment (FMA). This instrument measures upper extremity motor impairment including balance, coordination and speed. Secondary outcome measures for motor function will include (1) Box and Block Test: a timed test in which subjects are required to transfer 1-inch wooden blocks from one side of the box to another. It measures upper extremity manual dexterity and gross motor coordination. (2) Modified Ashworth Scale: is a 6-point measure of spasticity. We will assess the severity of spasticity at the shoulder, elbow, wrist and fingers. (3) Grip strength: will be measured using a hand-held dynamometer.In addition, we will monitor for adverse effects with a questionnaire documenting pain and discomfort at stimulation site, mood changes (using the Beck Depression Inventory), fatigue (using the Fatigue Severity Scale), and cognitive change (using the forward and backward digit span).Assessment of cortical excitability ? single and paired pulse TMS Another aim of this study is to investigate the mechanisms of this combined treatment on cortical plasticity as indexed by cortical excitability changes - assessed by single and paired pulse TMS. We will investigate the resting motor threshold, measured according to the technique of Rossini et al., 1994, before and after treatment, according to the schedule of outcome measures above; paired-pulse stimulation, measuring changes in intracortical facilitation and inhibition.
MRI protocol Patients will be scanned at -2, 0 and 4 weeks to investigate short-term and medium-term changes in fMRI and DTI parameters following tDCS/BCI and sham/BCI treatment. 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.The data analysis will include image registration, estimation of diffusion tensor parameters including Apparent Diffusion Coefficient, Fractional Anisotropy, axial and radial diffusivities and tractography using Camino. Reversed phase encoding EPI distortion correction, and regression analysis of DTI, TMS and clinical findings will be performed using Matlab.For fMRI, images will be obtained during the resting state, active/passive hand movement and during imagined arm movement. For the imagined arm movement, subjects will be asked to watch a video on a screen to guide their performance of the imagined movement.
- Conditions
- Stroke
- Being tested
- real-tDCS with MI-BCI
- Keywords
- Stroke, Noninvasive brain stimulation, Brain-computer interface, Motor imagery, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-tDCS with MI-BCIDevice
As in Arm Description
| Study group | Role | What they receive |
|---|---|---|
| real-tDCS with MI-BCI | Active comparator | 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. Receives: Device: real-tDCS with MI-BCI |
| sham-tDCS with MI-BCI | Sham comparator | 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. Receives: Device: real-tDCS with MI-BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Component of Fugl-Meyer Assessment
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).
Measured: week 0, week 2, week 4
Secondary outcomes (4)
Resting Motor Threshold of Stroke Affected M1 Motor Cortex
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.
Measured: pre- and post-training, 4 weeks post-training
Grip Strength
Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.
Measured: pre- and post-training, and again at 4 weeks post-training
Box and Block Test
Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.
Measured: pre and post training, and 4 weeks post training
MRI Parameters
active and passive fMRI, DTI, This part of data is still under analyzing.
Measured: -2, 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Health System, Singapore, Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- Effie Chew, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897025
- Sponsor's protocol ID
- NIG09may022
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2013
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411Chew E, Teo WP, Tang N, Ang KK, Ng YS, Zhou JH, Teh I, Phua KS, Zhao L, Guan C. Using Transcranial Direct Current Stimulation to Augment the Effect of Motor Imagery-Assisted Brain-Computer Interface Training in Chronic Stroke Patients-Cortical Reorganization Considerations. Front Neurol. 2020 Aug 27;11:948. doi: 10.3389/fneur.2020.00948. eCollection 2020.
PubMed 32973672Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
PubMed 25721551
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01897025
- Acronym / sponsor ID
- NIG09may022
- Conditions
- Stroke
- Keywords
- Stroke, Noninvasive brain stimulation, Brain-computer interface, Motor imagery, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University Health System, Singapore, Agency for Science, Technology and Research
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomised controlled trial of 32 subjects who have sustained their first ever subcortical stroke more than 9 months prior to study enrollment, with upper extremity impairment of 11-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale.
Subjects will be randomly allocated to one of the following 2 groups by using a computer-generated random sequence:
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of tDCS preceding training.
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of sham-tDCS preceding training. tDCS-BCI protocol Each of the 10 sessions of tDCS-BCI or sham-BCI will be conducted as follows: tDCS will be performed for 20 minutes immediately prior to each session of motor training. The anode will be placed over the M1 motor cortex of the affected hemisphere while the cathode will be placed over the unaffected M1.
After initial calibration, MI-BCI training will involve MI 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 and will be undertaken by a research assistant blinded to the condition of tDCS.
Outcome measures Improvement in motor functional ability will be the main outcome of this study. Outcome measures will be assessed at the following time points: prior to treatment initiation, at week 2 (immediate post-training period) and week 6 (4 weeks after completion of training). A clinician blinded to the treatment condition will assess the effects of the intervention. Our primary outcome measure will be the upper extremity score of the Fugl-Meyer Assessment (FMA). This instrument measures upper extremity motor impairment including balance, coordination and speed. Secondary outcome measures for motor function will include (1) Box and Block Test: a timed test in which subjects are required to transfer 1-inch wooden blocks from one side of the box to another. It measures upper extremity manual dexterity and gross motor coordination. (2) Modified Ashworth Scale: is a 6-point measure of spasticity. We will assess the severity of spasticity at the shoulder, elbow, wrist and fingers. (3) Grip strength: will be measured using a hand-held dynamometer.In addition, we will monitor for adverse effects with a questionnaire documenting pain and discomfort at stimulation site, mood changes (using the Beck Depression Inventory), fatigue (using the Fatigue Severity Scale), and cognitive change (using the forward and backward digit span).Assessment of cortical excitability ? single and paired pulse TMS Another aim of this study is to investigate the mechanisms of this combined treatment on cortical plasticity as indexed by cortical excitability changes - assessed by single and paired pulse TMS. We will investigate the resting motor threshold, measured according to the technique of Rossini et al., 1994, before and after treatment, according to the schedule of outcome measures above; paired-pulse stimulation, measuring changes in intracortical facilitation and inhibition.
MRI protocol Patients will be scanned at -2, 0 and 4 weeks to investigate short-term and medium-term changes in fMRI and DTI parameters following tDCS/BCI and sham/BCI treatment. 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.The data analysis will include image registration, estimation of diffusion tensor parameters including Apparent Diffusion Coefficient, Fractional Anisotropy, axial and radial diffusivities and tractography using Camino. Reversed phase encoding EPI distortion correction, and regression analysis of DTI, TMS and clinical findings will be performed using Matlab.For fMRI, images will be obtained during the resting state, active/passive hand movement and during imagined arm movement. For the imagined arm movement, subjects will be asked to watch a video on a screen to guide their performance of the imagined movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-tDCS with MI-BCI | Active comparator | Device: real-tDCS with MI-BCI10 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. |
| sham-tDCS with MI-BCI | Sham comparator | Device: real-tDCS with MI-BCI10 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- epilepsy
- neglect
- cognitive impairment
- other neurological or psychiatric diseases
- severe arm pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-tDCS with MI-BCIAs in Arm Description | Device | real-tDCS with MI-BCI, sham-tDCS with MI-BCI |
Primary outcome
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).
4 secondary outcomes
Resting Motor Threshold of Stroke Affected M1 Motor Cortex
Time frame: pre- and post-training, 4 weeks post-training
Grip Strength
Time frame: pre- and post-training, and again at 4 weeks post-training
Box and Block Test
Time frame: pre and post training, and 4 weeks post training
MRI Parameters
Time frame: -2, 0 and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Derived from this study: PubMed 32973672Chew E, Teo WP, Tang N, Ang KK, Ng YS, Zhou JH, Teh I, Phua KS, Zhao L, Guan C. Using Transcranial Direct Current Stimulation to Augment the Effect of Motor Imagery-Assisted Brain-Computer Interface Training in Chronic Stroke Patients-Cortical Reorganization Considerations. Front Neurol. 2020 Aug 27;11:948. doi: 10.3389/fneur.2020.00948. eCollection 2020.
- Derived from this study: PubMed 25721551Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Effie Chew, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing real-tDCS with MI-BCI in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Component of Fugl-Meyer Assessment (time frame: week 0, week 2, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01897025, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.