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The RETRAIN Trial Phase 2

NCT07197996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-30

No results posted yet for this study

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

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 and haemodynamics.

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

Sponsors & Collaborators

  • Innovate UK

    collaborator OTHER_GOV

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • Kausik Chatterjee · COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-03-01
Completion
2026-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07197996 on ClinicalTrials.gov