The RETRAIN Trial Phase 2

NCT07197996 | Recruiting

• 2 other identifiers: ISS-BBF-00210038715
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ischaemic Stroke

Keywords

Acute ischemic stroke; Neuromuscular electrostimulation; Effects on cerebral blood flow; Randomised controlled trial; Cerebral blood flow measurements; Stroke rehabilitation

Outcome Measures

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.

  Day 1-2 (within 36 hours of stroke onset; measurements taken twice daily for 2 consecutive days)

Secondary Outcomes (7)

• Change in Neurovascular Coupling During Device Use

  Day 1-2 (twice daily assessments for 2 consecutive days)

• Change in Dynamic Cortical Connectivity During Device Use

  Day 1-2 (twice daily assessments for 2 consecutive days)

• Incidence of Adverse Events

  Up to 2 days from enrolment

• Incidence of Serious Adverse Events

  Up to 2 days from enrolment

• Incidence of Adverse Device Effects

  Up to 2 days from enrolment

Study Arms (2)

Group 1 - IPC device

EXPERIMENTAL

IPC sleeves applied bilaterally according to manufacturer's instructions for standard VTE prophylaxis following ischaemic stroke.

Device: Intermittent Pneumatic Compression

Group 2 - geko® device

EXPERIMENTAL

The geko® device is a disposable, battery-powered neuromuscular electrostimulation device applied bilaterally to the peroneal nerve at the knee. It delivers low-frequency stimulation to activate the calf and foot muscle pumps, enhancing venous return and microcirculatory blood flow. Devices will be applied according to the manufacturer's instructions for VTE prophylaxis.

Device: geko® T3

Interventions

Intermittent Pneumatic Compression DEVICE

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 and haemodynamics.

Also known as: Kendall SCD™ 700 Sequential Compression System

Group 1 - IPC device

geko® T3 DEVICE

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 stimulation vs. external compression) and will be evaluated for its impact on cerebral haemodynamics, neurovascular coupling, and dynamic cerebral autoregulation during VTE prophylaxis.

Also known as: geko® device, neuromuscular electrostimulation

Group 2 - geko® device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Firstkind Ltd: lead
• Innovate UK: collaborator

Study Sites (1)

Countess of Chester Hospital

Chester, Cheshire, CH2 1UL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Kausik Chatterjee

  COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST

  STUDY DIRECTOR

Central Study Contacts

Pramodh Hettiarachchi, MRCP

CONTACT

+44 1244 365000; phettiarachchi@nhs.net

Kausik Chatterjee, FRCP, MD

CONTACT

+44 1244362618; kausikchatterjee@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Assignment

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 30, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD will be available beginning 12 months after publication of the primary results and for a period of up to 5 years thereafter.
• Access Criteria: Researchers must submit a methodologically sound proposal, which will be reviewed by the sponsor and chief investigator. Access will be granted only after a data sharing agreement is signed.

Locations

GB (1)