The RETRAIN Trial Phase 2
ConditionIschaemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirstkind Ltd
About this trial
Ischaemic strokes, caused by a disruption in the brain's blood supply, are the second leading cause of death and disability in the United Kingdom. This single-center prospective randomised study aims to measure cerebral blood flow and oxygen delivery in patients who have recently suffered an ischaemic stroke and are using either the geko® neuromuscular electrostimulation device or an intermittent pneumatic compression (IPC) device as part of their routine clinical care.
The geko® device stimulates a nerve in the lower leg, inducing muscle contractions that enhance blood circulation. The IPC device applies controlled external pressure through compressed air and a pump, cyclically inflating and deflating chambers in a sleeve worn on the leg. This mimics the action of calf muscles to promote blood flow.
The primary objective of this study is to assess the effect of the geko® and IPC devices on cerebral blood flow in stroke patients, specifically during the hyperacute phase (within 36 hours) following an ischaemic stroke. Both devices will be used as part of standard care for VTE prevention. Cerebral blood flow will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult over 18
Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
Within 36 hours of symptom onset.
Unable to stand or mobilise without assistance.
Disqualifiers
Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee.
Absence of a transient ischaemic attack (TIA).
Clinically apparent deep vein thrombosis at screening
Patient is expected to require palliative care within 14 days
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Pneumatic Compression
DeviceThe IPC arm will use the Kendall SCD™ 700 Sequential Compression System, a routinely employed device for VTE prophylaxis in stroke patients. In this study, IPC sleeves will be applied bilaterally to the legs within 36 hours of stroke onset and operated according to the manufacturer's instructions. The intervention is distinguished by its cyclical external leg compression to enhance venous return, and it serves as the comparator to the geko® device for evaluating effects on cerebral blood flow and haemodynamics.
geko® T3
DeviceThe geko® T3 device is a small, disposable, battery-powered neuromuscular electrostimulation device manufactured by Firstkind Ltd. In this study, the geko® will be applied bilaterally to the common peroneal nerve at the knee within 36 hours of stroke onset. It delivers transcutaneous electrical stimulation at 1 Hz, producing involuntary rhythmic foot dorsiflexion to activate the calf and foot muscle pumps. The intervention is distinguished from IPC by its mechanism of action (neuromuscular stimulation vs. external compression) and will be evaluated for its impact on cerebral haemodynamics, neurovascular coupling, and dynamic cerebral autoregulation during VTE prophylaxis.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Group 1 - IPC deviceExperimental treatment 1 intervention
Group B: Group 2 - geko® deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cerebral Blood Flow During Device Use
Cerebral blood flow (CBF) will be assessed using functional near-infrared spectroscopy (fNIRS) combined with EEG, beat-to-beat blood pressure, and transcutaneous CO₂ monitoring. Measurements will compare baseline (no device) to during active use of either the Intermittent Pneumatic Compression (IPC) device or the geko® T3 device. The primary analysis will evaluate differences in cerebral haemodynamics between the two randomized intervention groups.
Time frame
Day 1-2 (within 36 hours of stroke onset; measurements taken twice daily for 2 consecutive days)Secondary outcomes
1
Change in Neurovascular Coupling During Device Use
Changes in neurovascular coupling will be assessed using combined functional near-infrared spectroscopy (fNIRS) and EEG during resting state and during active use of the Intermittent Pneumatic Compression (IPC) device or the geko® T3 device.
Time frame
Day 1-2 (twice daily assessments for 2 consecutive days)2
Change in Dynamic Cortical Connectivity During Device Use
Functional connectivity between cortical regions will be measured using fNIRS+EEG data during intervention (IPC or geko® device) compared to baseline.
Time frame
Day 1-2 (twice daily assessments for 2 consecutive days)3
Incidence of Adverse Events
Number and type of adverse events observed in participants during and after use of either device.
Time frame
Up to 2 days from enrolment4
Incidence of Serious Adverse Events
Frequency of serious adverse events, including death, life-threatening illness, permanent impairment, or prolonged hospitalisation
Time frame
Up to 2 days from enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Firstkind Ltd
Lead sponsor
Innovate UK
Collaborator
Source ClinicalTrials.gov