NCT04353297Completed
BCI-assisted MI Intervention in Subacute Stroke
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
Source: ClinicalTrials.gov · Last updated 28 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 15 Apr 2020
- Start date
- 28 Jan 2021
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Stroke
- NCT number
- NCT04353297
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From 28 Jan 2021 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant neurological disorders
Other illness
- dementia;
Other
- severe neglect and aphasia;
- 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;
Who the study is looking for
- first ever unilateral stroke - confirmed by MRI;
- hemiplegia/hemiparesis from 1 to 6 months since stroke;
- age between 18 and 80 years;
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.