BCI-assisted MI Intervention in Subacute Stroke

NCT04353297 | Completed DMC

• 1 other identifier: RF-2018-12365210
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs are critically needed. Brain-Computer Interface (BCI) systems which enable the modulation of EEG sensorimotor rhythms are promising tools to promote early improvements of motor rehabilitation outcomes after stroke. This project intends to boost this BCI application beyond the state of art by providing: i) evidence for a short/long-term efficacy in enhancing post-stroke functional hand motor recovery; and ii) quantifiable indices (beyond clinical scales) sensitive to stroke participant's response to a Promotoer (BCI system compatible with clinical setting) -based intervention. To these aims, a longitudinal randomized controlled trial will be performed in which, subacute stroke participants will undergo a Promotoer- assisted hand motor imagery training.

Conditions

Stroke; Motor Disorders

Keywords

Stroke; Brain-Computer Interface; Motor Imagery; Motor Rehabilitation; Brain Plasticity

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline on the Fugl-Meyer scores for Upper Extremity-Motor Control at end of intervention

  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)

  End of treatment at 48-hours post-intervention (T1)

Secondary Outcomes (7)

• Mean change from T1 on Fugl-Meyer scores for Upper Extremity-Motor Control [International Classification Function: body function] at 6 months follow-up

  Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)

• Minimal Clinical Important Difference (MCID) at Fugl-Meyer Upper Extremity

  Up to 6 month follow-up: T2 (1 month post-intervention), T3 (3 months post-intervention), and T4 (6 months post-intervention)

• Mean change from baseline on Modified Ashworth Scale (MAS) at end of intervention and follow-up

  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)

• Mean change from baseline on Numeric Rating Scale for pain in the affected arm

  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)

• Mean change from baseline on Action Research Arm Test (ARAT) at end of intervention and follow-up

  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)

Other Outcomes (4)

• Changes from baseline on high density Electroencephalography (hdEEG) patterns of cortical oscillatory activity and connectivity at end of intervention and follow-up

  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)

• Structural Magnetic Resonance Imaging (MRI) of the whole brain

  After randomization/before beginning of treatment (T0) and at 3 months follow-up (T3)

• Motor Evoked Potentials (MEPs) upper limbs

  After randomization/before beginning of treatment (T0)

Study Arms (2)

BCI Group

EXPERIMENTAL

(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

Other: EEG-based BCI system for (hand) Motor Imagery training

Control Group

ACTIVE COMPARATOR

MI training without BCI support delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

Other: Motor Imagery training

Interventions

EEG-based BCI system for (hand) Motor Imagery training OTHER

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).

Also known as: BCI- MI Intervention

BCI Group

Motor Imagery training OTHER

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).

Also known as: Control- MI Intervention

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first ever unilateral stroke - confirmed by MRI;
• hemiplegia/hemiparesis from 1 to 6 months since stroke;
• age between 18 and 80 years;

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• University of Roma La Sapienza: collaborator
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS

Rome, 00179, Italy

Location

Related Publications (13)

• 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.

  PMID: 26486867 RESULT

• 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.

  PMID: 25712802 RESULT

• 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.

  PMID: 23494615 RESULT

• 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.

  PMID: 29925890 RESULT

• 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.

  PMID: 23366832 RESULT

• 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.

  PMID: 25721550 RESULT

• 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.

  PMID: 29761128 RESULT

• 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.

  PMID: 22023891 RESULT

• 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.

  PMID: 24803495 RESULT

• 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.

  PMID: 21926382 RESULT

• 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.

  PMID: 17148468 RESULT

• Cipriani M, Pichiorri F, Colamarino E, Toppi J, Tamburella F, Lorusso M, Bigioni A, Morone G, Tomaiuolo F, Santoro F, Cordella D, Molinari M, Cincotti F, Mattia D, Puopolo M. The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial. Trials. 2023 Nov 16;24(1):736. doi: 10.1186/s13063-023-07773-4.

  PMID: 37974284 DERIVED

• 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.

  PMID: 32593293 DERIVED

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Donatella Mattia, MD,PhD

  Fondazione Santa Lucia, IRCCS

  STUDY CHAIR

• Marco Molinari, MD, PhD

  Fondazione Santa Lucia, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, laboratory director

Model Details: Eligible subacute stroke patients admitted to Fondazione Santa Lucia Hospital for standard rehabilitation care will be randomized in equal proportions (1:1 ratio) between Promotoer- BCI (BCI-assisted MI training- EXP) and Control (MI training-no BCI supported).

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: January 28, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)