BCI-assisted MI Intervention in Subacute Stroke (Promotoer)
The PROMOTOER: a BCI -Based Intervention That Promotes Upper Limb Functional Motor Recovery. A Randomized Clinical Trial to Test Long-term Efficacy and to Identify Determinants of Response to Intervention in Subacute Stroke Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Giovanni Morone, Md, PhD
- Phone Number: +390651501005
- Email: g.morone@hsantalucia.it
Study Contact Backup
- Name: Fulvia Di Iulio, PhD
- Phone Number: +390651501829
- Email: f.diiulio@hsantalucia.it
Study Locations
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Rome, Italy, 00179
- Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- first ever unilateral stroke - confirmed by MRI;
- hemiplegia/hemiparesis from 1 to 6 months since stroke;
- age between 18 and 80 years;
Exclusion Criteria:
- severe neglect and aphasia;
- dementia;
- severe spasticity - Modified Ashworth Scale >4 at shoulder/elbow/wrist;
- Upper Extremity Fugl-Meyer Assessment (UE-FMA) >47/60 score (60 is without considering 6 score point for tendon reflexes);
- Token test >29 score;
- concomitant neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Experimental: BCI Group
(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).
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The Promotoer is an all-in-one BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback (EEG and EMG activity monitoring) and screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands.
As such, this software allows the therapists to create an artificial reproduction of a given patient's hand/forearm by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hand/forearm.
Training consists of the MI tasks only of the affected hand, grasping or finger extension in separate runs.
The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group.
Each training session will consist of 4 runs (20 trials each).
Other Names:
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Active Comparator: Control Group
MI training without BCI support delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).
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Training consists of MI tasks only of the affected hand, grasping or finger extension in separate runs.
MI training will be delivered without BCI support (ie., the Promotoer system will not provide real-time feedback of MI performance; hand/forearm visual representation will remain standstill) with a dose/setting regimen equivalent to EXP intervention.
The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec.
Each training session will consist of 4 runs (20 trials each).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean change from baseline on the Fugl-Meyer scores for Upper Extremity-Motor Control at end of intervention
Time Frame: End of treatment at 48-hours post-intervention (T1)
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Fugl-Meyer scores for Upper Extremity-Motor Control (range from 0- minimum to 66-maximum points where 66-maximum is normal) [International Classification Function: body function] assessed in both BCI-based and Control intervention groups (superiority of BCI-based intervention vs Control intervention in improving hand motor function outcome)
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End of treatment at 48-hours post-intervention (T1)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean change from T1 on Fugl-Meyer scores for Upper Extremity-Motor Control [International Classification Function: body function] at 6 months follow-up
Time Frame: Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Fugl-Meyer scores for Upper Extremity-Motor Control (range from 0- minimum to 66-maximum points, where 66-maximum is normal) [International Classification Function: body function] assessed in both BCI-based and Control intervention groups at follow-up time points (long-term efficacy of BCI -based intervention)
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Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Minimal Clinical Important Difference (MCID) at Fugl-Meyer Upper Extremity
Time Frame: Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Proportion of the patients that will achieve the MCID at Fugl-Meyer Upper Extremity Motor , in BCI -intervention Group Vs Control- intervention Group.
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Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Mean change from baseline on Modified Ashworth Scale (MAS) at end of intervention and follow-up
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Measure of arm spasticity (at shoulder + elbow + hand) as measured by means of MAS (score from 0 to 5 points, where 0 is equal to absence of spasticity, 5 is equal to high degree of spasticity)
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Mean change from baseline on Numeric Rating Scale for pain in the affected arm
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Measure of arm perceived pain by means of Numeric Rating Scale (score from 0 to 10 points where 0 is equal to NO PAIN and 10 is equal to UNSPEAKABLE PAIN)
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Mean change from baseline on Action Research Arm Test (ARAT) at end of intervention and follow-up
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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ARAT assessed in both BCI-based and Control intervention groups at end of treatment and follow-up time points (long-term efficacy of BCI -based intervention)
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Mean change from baseline on National Institute of Health Stroke Scale (NIHSS) at end of intervention and follow-up
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Measure of severity of stroke symptoms as for the National Institute of Health Stroke Scale-NIHSS (composed by 11 items with a total score ranging from 0 to a maximum depending on each item, where 0 is normal and maximum is pathological response)
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Mean change on Manual Muscle Test (MMT) for affected arm at end of intervention and follow-up
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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MMT for affected arm shoulder/elbow/wrist (flexor/extensor muscles) in both BCI-based and Control intervention groups at end of treatment and follow-up time points (long-term efficacy of BCI -based intervention)
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes from baseline on high density Electroencephalography (hdEEG) patterns of cortical oscillatory activity and connectivity at end of intervention and follow-up
Time Frame: End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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EEG recordings (motor relevant oscillatory activity and functional connectivity to evaluate the neurophysiological substrates of the experimental intervention efficacy, in both BCI-based and Control intervention groups at end of treatment and follow-up time points
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End of treatment at 48-hours post-intervention (T1) and up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)
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Structural Magnetic Resonance Imaging (MRI) of the whole brain
Time Frame: After randomization/before beginning of treatment (T0) and at 3 months follow-up (T3)
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structural MRI to evaluate lesion size/site and white matter alteration in both experimental and Control groups as factor influencing experimental intervention response
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After randomization/before beginning of treatment (T0) and at 3 months follow-up (T3)
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Motor Evoked Potentials (MEPs) upper limbs
Time Frame: After randomization/before beginning of treatment (T0)
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MEPs elicited via Transcranial Magnetic Stimulation (TMS) to evaluate the integrity of the Cortico Spinal Tract (CST) in both experimental and Control groups as factor influencing experimental intervention response
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After randomization/before beginning of treatment (T0)
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Test for Attentional Performance (TAP) at baseline
Time Frame: At screening for inclusion
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TAP (3 items: alertness, sustained attention and working memory) to evaluate attention participant profile in both experimental and control groups as a factor influencing experimental intervention response
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At screening for inclusion
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Donatella Mattia, MD,PhD, Fondazione Santa Lucia, IRCCS
- Principal Investigator: Marco Molinari, MD, PhD, Fondazione Santa Lucia, IRCCS
Publications and helpful links
General Publications
- Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.
- Kim AS, Cahill E, Cheng NT. Global Stroke Belt: Geographic Variation in Stroke Burden Worldwide. Stroke. 2015 Dec;46(12):3564-70. doi: 10.1161/STROKEAHA.115.008226. Epub 2015 Oct 20. No abstract available.
- Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.
- Biasiucci A, Leeb R, Iturrate I, Perdikis S, Al-Khodairy A, Corbet T, Schnider A, Schmidlin T, Zhang H, Bassolino M, Viceic D, Vuadens P, Guggisberg AG, Millan JDR. Brain-actuated functional electrical stimulation elicits lasting arm motor recovery after stroke. Nat Commun. 2018 Jun 20;9(1):2421. doi: 10.1038/s41467-018-04673-z.
- Cincotti F, Pichiorri F, Arico P, Aloise F, Leotta F, de Vico Fallani F, Millan Jdel R, Molinari M, Mattia D. EEG-based Brain-Computer Interface to support post-stroke motor rehabilitation of the upper limb. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4112-5. doi: 10.1109/EMBC.2012.6346871.
- Morone G, Pisotta I, Pichiorri F, Kleih S, Paolucci S, Molinari M, Cincotti F, Kubler A, Mattia D. Proof of principle of a brain-computer interface approach to support poststroke arm rehabilitation in hospitalized patients: design, acceptability, and usability. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S71-8. doi: 10.1016/j.apmr.2014.05.026.
- Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.
- Coupar F, Pollock A, Rowe P, Weir C, Langhorne P. Predictors of upper limb recovery after stroke: a systematic review and meta-analysis. Clin Rehabil. 2012 Apr;26(4):291-313. doi: 10.1177/0269215511420305. Epub 2011 Oct 24.
- Fleming MK, Sorinola IO, Roberts-Lewis SF, Wolfe CD, Wellwood I, Newham DJ. The effect of combined somatosensory stimulation and task-specific training on upper limb function in chronic stroke: a double-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):143-52. doi: 10.1177/1545968314533613. Epub 2014 May 6.
- Kantak SS, Stinear JW, Buch ER, Cohen LG. Rewiring the brain: potential role of the premotor cortex in motor control, learning, and recovery of function following brain injury. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):282-92. doi: 10.1177/1545968311420845. Epub 2011 Sep 16.
- Stinear CM, Barber PA, Smale PR, Coxon JP, Fleming MK, Byblow WD. Functional potential in chronic stroke patients depends on corticospinal tract integrity. Brain. 2007 Jan;130(Pt 1):170-80. doi: 10.1093/brain/awl333.
- Mattia D, Pichiorri F, Colamarino E, Masciullo M, Morone G, Toppi J, Pisotta I, Tamburella F, Lorusso M, Paolucci S, Puopolo M, Cincotti F, Molinari M. The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response. BMC Neurol. 2020 Jun 27;20(1):254. doi: 10.1186/s12883-020-01826-w.
Study record dates
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Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
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First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
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Last Update Submitted That Met QC Criteria
Last Verified
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More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RF-2018-12365210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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