Last reviewed · How we verify
NCT04353297: Promotoer
BCI-assisted MI Intervention in Subacute Stroke
NA trial testing EEG-based BCI system for (hand) Motor Imagery training in Stroke in 49 participants. Completed in 1 December 2023.
31 October 2023
Quick facts
| Lead sponsor | I.R.C.C.S. Fondazione Santa Lucia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 28 January 2021 |
| Primary completion | 31 October 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- EEG-based BCI system for (hand) Motor Imagery training
- Motor Imagery training
Conditions studied
- Stroke — all drugs for Stroke →
- Motor Disorders — all drugs for Motor Disorders →
Sponsor
I.R.C.C.S. Fondazione Santa Lucia — full company profile →
Who can join
Adults 18 to 80, any sex, with Stroke or Motor Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Mattia D, Pichiorri F, Colamarino E, Masciullo M, et al · · 2020 · cited 19× · PMID 32593293 · DOI 10.1186/s12883-020-01826-w -
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.
Cipriani M, Pichiorri F, Colamarino E, Toppi J, et al · · 2023 · cited 4× · PMID 37974284 · DOI 10.1186/s13063-023-07773-4 -
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
Cipriani M, Pichiorri F, Colamarino E, Toppi J, et al · · 2023 · DOI 10.21203/rs.3.rs-3317549/v1
Verify or expand the search:
- PubMed search for NCT04353297
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stroke
Currently open trials in the same condition.
- NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
- NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
- NCT07356011 — Exoskeleton for Balance · NA · recruiting
- NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
- NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting
Other I.R.C.C.S. Fondazione Santa Lucia trials
Trials by the same sponsor.
- NCT07257679 — Gentle Touch for Post-Mastectomy Lymphedema · Phase 4 · recruiting
- NCT07254377 — Design and Validation of Innovative Strategies Based on Dual-Task Approach · NA · active not recruiting
- NCT06420271 — Effects of Cerebellar tACS-iTBS in Ataxia · NA · recruiting
- NCT06911671 — EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA) · NA · recruiting
- NCT07075770 — Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04353297 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by I.R.C.C.S. Fondazione Santa Lucia
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04353297.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing