The RETRAIN Trial Phase 2

Official title

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)

Overview

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).

Detailed description

This study is a randomised trial at a single centre, comparing brain blood flow and activity patterns when two standard treatments for preventing blood clots (VTE) are used following a stroke.

Who Can Take Part?

Patients will be identified for the study as part of their routine hospital care when they arrive at hospital through the emergency department. To take part they must:

1. Be 18 years or older 2. Have had an ischaemic stroke confirmed by a stroke doctor 3. Be within 36 hours of stroke symptom onset 4. Be unable to stand or move around 5. Have had a CT or MRI scan confirming no bleeding in the brain

What Will Happen?

After confirming eligibility and once consent is given, 80 participants will be randomly assigned to one of two groups during the study period:

Group 1 - IPC device Group 2 - geko® device

Both devices are standard treatments for preventing blood clots.

Study Assessments

Brain blood flow will be measured while participants are sitting upright in bed. Each session will include:

5 minutes with the device switched off 5 minutes with the device switched on

These assessments will take place twice a day for two days (a total of 40 minutes) with a pre-assessment preparation (a total of 80 minutes over the two days). Blood pressure, ECG, temperature, and oxygen levels will be continuously monitored. No follow-up is required after the study.

Interventions

• Device Intermittent Pneumatic Compression
  The 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 an
• Device geko® T3
  The 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 stimu

Primary outcome measures

• Change in Cerebral Blood Flow During Device Use [Time frame: Day 1-2 (within 36 hours of stroke onset; measurements taken twice daily for 2 consecutive days)]

Secondary outcome measures (7)

• Change in Neurovascular Coupling During Device Use [Time frame: Day 1-2 (twice daily assessments for 2 consecutive days)]
• Change in Dynamic Cortical Connectivity During Device Use [Time frame: Day 1-2 (twice daily assessments for 2 consecutive days)]
• Incidence of Adverse Events [Time frame: Up to 2 days from enrolment]
• Incidence of Serious Adverse Events [Time frame: Up to 2 days from enrolment]
• Incidence of Adverse Device Effects [Time frame: Up to 2 days from enrolment]
• Incidence of Serious Adverse Device Effects [Time frame: Up to 2 days from enrolment]
• Incidence of Device Deficiencies [Time frame: Up to 2 days from enrolment]

Eligibility criteria

Inclusion criteria

• 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.
• No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan.

Exclusion criteria

• 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
• 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.
• Contraindications for the use of the geko™ device

• Allergy to hydrogel constituents
• 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).
• Single or double leg amputations.
• Participation in any other clinical trial
• Patients must not have a current coronavirus (COVID-19) infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Countess of Chester Hospital — Chester

Identifiers

NCT: NCT07197996 · ISS-BBF-002 · 10038715

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗