DiSCIoser: Improving Arm Sensorimotor Functions After Spinal Cord Injury Via Brain-Computer Interface Training

NCT05637775 | Completed DMC

• 1 other identifier: RF-2019-12369396
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to validate the efficacy of a Brain-Computer Interface (BCI)-based intervention for hand motor recovery in subacute cervical spinal cord injured (SCI) patients during rehabilitation. The study will provide evidence for the clinical/neurophysiological efficacy of the BCI intervention as a means to promote cortical sensorimotor plasticity (remote plasticity) and thus maximize recovery of arm functions in subacute cervical SCI. Participants will undergo an extensive clinical, neurophysiological, neuropsychological and neuroimaging assessment before and after a BCI training based on motor Imagery (MI) of hands. The intervention will be delivered with a system that was originally validated for stroke patients and adapted to the aims of this study. Researchers will compare the BCI intervention with an active MI training without BCI support (active comparator).

Conditions

Spinal Cord Injuries; Motor Disorders

Keywords

spinal cord injury; brain computer interface; motor imagery; motor rehabilitation; neurorehabilitation; brain plasticity

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory scores of bilateral arms at end of intervention

  The GRASSP scale (somatosensory sub-section) ranges from 0 (maximum impairment) to 12 (normal) for each side arm.

  Pre-Randomization, Post Training (within 48 hours)

Secondary Outcomes (4)

• Mean change from baseline on Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) motor scores of bilateral arms at end of intervention

  Pre-Randomization, Post Training (within 48 hours)

• Mean change from baseline in the Spinal Cord Injury Independence Measure (SCIM) - self care section

  Pre-Randomization, Post Training (within 48 hours)

• Mean change in Pain as assessed by the International SCI Pain Basic Dataset (ISCIPBDS)

  Pre-Randomization, Post Training (within 48 hours)

• Mean change in Upper Extremity Motor Score (UEMS) from the ISNCSCI AIS evaluation

  Pre-Randomization, Post Training (within 48 hours)

Other Outcomes (4)

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

  Pre-Randomization, Post Training (within 1 week)

• Changes in Motor Evoked Potentials (MEPs)

  Pre-Randomization, Post Training (within 1 week)

• Changes in Somatosensory Evoked Potentials (SSEPs)

  Pre-Randomization, Post Training (within 1 week)

Study Arms (2)

EXP - BCI

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 (hands) Motor Imagery training

CTRL - MI

ACTIVE COMPARATOR

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

Other: Control - MI intervention

Interventions

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

For the purposes of this study we adapted an available BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback and a 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. This software allows the therapists to create an artificial reproduction of patient's hands/forearms by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hands/forearms. Training consists of the MI tasks of both hands, 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 - EXP

EXP - BCI

Control - MI intervention OTHER

Training consists of MI tasks of both hands, grasping or finger extension in separate runs. MI training will be delivered 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: MI - CTRL

CTRL - MI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subacute cervical SCI (30-90 days from event)
• classification according to ISNCSCI AIS A-D, lesion level C1-T1
• Upper Extremity Motor Score (UEMS) \< 40

You may not qualify if:

• other conditions (present or previous) potentially affecting sensorimotor upper limb function
• inability to give informed consent and understand the requirements for the training

Sponsors & Collaborators

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

Study Sites (1)

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS

Rome, Italy, 00179, Italy

Location

Related Publications (5)

• 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 BACKGROUND

• Donati AR, Shokur S, Morya E, Campos DS, Moioli RC, Gitti CM, Augusto PB, Tripodi S, Pires CG, Pereira GA, Brasil FL, Gallo S, Lin AA, Takigami AK, Aratanha MA, Joshi S, Bleuler H, Cheng G, Rudolph A, Nicolelis MA. Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Sci Rep. 2016 Aug 11;6:30383. doi: 10.1038/srep30383.

  PMID: 27513629 BACKGROUND

• Brown AR, Martinez M. From cortex to cord: motor circuit plasticity after spinal cord injury. Neural Regen Res. 2019 Dec;14(12):2054-2062. doi: 10.4103/1673-5374.262572.

  PMID: 31397332 BACKGROUND

• 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 BACKGROUND

• Colamarino E, Lorusso M, Pichiorri F, Toppi J, Tamburella F, Serratore G, Riccio A, Tomaiuolo F, Bigioni A, Giove F, Scivoletto G, Cincotti F, Mattia D. DiSCIoser: unlocking recovery potential of arm sensorimotor functions after spinal cord injury by promoting activity-dependent brain plasticity by means of brain-computer interface technology: a randomized controlled trial to test efficacy. BMC Neurol. 2023 Nov 21;23(1):414. doi: 10.1186/s12883-023-03442-w.

  PMID: 37990160 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Mental Disorders

Study Officials

• Donatella Mattia, MD, PhD

  Fondazione Santa Lucia, IRCCS

  PRINCIPAL INVESTIGATOR

• Giorgio Scivoletto, MD, PhD

  Fondazione Santa Lucia, IRCCS

  PRINCIPAL INVESTIGATOR

• Febo Cincotti, MD, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors performing clinical evaluation and data analysts will be blinded to patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Laboratory Director

Model Details: Eligible subacute cervical SCI patients admitted to Fondazione Santa Lucia Hospital for standard rehabilitation care will be randomized in equal proportions (1:1 ratio) between BCI-assisted MI training- EXP) and Control (MI without BCI - CTRL).

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 5, 2022
• Study Start: November 15, 2022
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)