NCT03379532Completed
BCI-controlled NMES in Subacute Stroke
Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage. Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections. Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles. In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 14 Dec 2017
- Start date
- 26 Jan 2018
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- University Hospital, Geneva
- Diseases
- Stroke
- NCT number
- NCT03379532
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 26 Jan 2018 to the primary completion date, 31 Mar 2024
- 2 sites in 2 countries
- 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
- Metallic implants in the brain
Other illness
- Second stroke during rehabilitation
- Cardiac pacemaker
- Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
Other
- Skull breach
- Delirium or disturbed vigilance
- Inability to follow treatments sessions
- Severe language comprehension deficits
- Severe dystonia or spasticity
- Pregnancy
Who the study is looking for
- Ischemic or hemorrhagic stroke
- Stroke onset ≤ 8 weeks
- Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- Ability to give informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Neurorehabilitation, University Hospital of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| University of Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.