Leg muscle stimulation versus pneumatic compression to boost brain blood flow after ischaemic stroke
MonitoRing the Effect of Intermittent Pneumatic Compression and TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve Using the Geko® Device on Cerebral Haemodynamics in Patients With Ischaemic Strokes (The RETRAIN Trial Phase 2)
This will test whether a neuromuscular leg-stimulating device (geko®) or an intermittent pneumatic compression (IPC) sleeve better increases brain blood flow in adults within 36 hours of an ischaemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Firstkind Ltd Industry-sponsored |
| Locations | 1 site (Chester, Cheshire) |
| Trial ID | NCT07197996 on ClinicalTrials.gov |
What this trial studies
This single-centre randomized study enrolls 80 adults with confirmed ischaemic stroke within 36 hours who cannot mobilize independently. Participants are randomly assigned to receive either the geko® neuromuscular electrostimulation device or standard IPC while cerebral blood flow and oxygen delivery are measured. Measurements consist of repeated 5-minute off/on device sessions twice daily for two days with continuous monitoring of blood pressure, ECG, temperature, and oxygen saturation. No longer-term follow-up is required and both devices are already used clinically for venous thromboembolism prevention.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed ischaemic stroke within 36 hours who cannot stand or mobilize independently and have no intracerebral haemorrhage on CT or MRI are eligible.
Not a fit: Patients more than 36 hours after symptom onset, those with intracerebral haemorrhage, those able to mobilize independently, or those with contraindications or no response to the geko® device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the result could identify a device that quickly improves cerebral perfusion after acute ischaemic stroke and inform bedside prevention strategies.
How similar studies have performed: Devices like IPC and neuromuscular electrical stimulation have evidence for preventing venous thromboembolism and improving peripheral circulation, but direct effects on cerebral blood flow in hyperacute stroke are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult over 18 2. Patient with ischaemic stroke diagnosis confirmed by a stroke physician. 3. Within 36 hours of symptom onset. 4. Unable to stand or mobilise without assistance. 5. No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Exclusion Criteria: 1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee. 2. Absence of a transient ischaemic attack (TIA). 3. Clinically apparent deep vein thrombosis at screening 4. Patient is expected to require palliative care within 14 days 5. No response to the geko® device i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting. 6. Contraindications for the use of the geko™ device * Allergy to hydrogel constituents 7. Contraindications to IPC * Severe peripheral vascular disease * Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion) * Severe oedema * Leg deformities making appropriate fitting impossible * Symptomatic congestive cardiac failure of NYHA class IV (symptoms of heart failure at rest, any physical activity causing further discomfort). 8. Single or double leg amputations. 9. Participation in any other clinical trial 10. Patients must not have a current coronavirus (COVID-19) infection
Where this trial is running
Chester, Cheshire
- Countess of Chester Hospital — Chester, Cheshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Pramodh Hettiarachchi, MRCP
- Email: phettiarachchi@nhs.net
- Phone: +44 1244 365000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.