The RETRAIN Trial (Phase 1)

The primary objective is to investigate in stroke patients the impact of geko™ NMES treatment, when used as standard of care for VTE prevention, on brain haemodynamics at different stimulation levels and in three different postural positions (supine, semi-supine [45° seated] and seated). The aim is to identify the optimal stimulation level and postural position for the maximum response (NMES versus no NMES) with regard to relative total haemoglobin concentration (i.e., the sum of relative deoxyhaemoglobin and oxyhaemoglobin concentrations) using fNIRS and EEG.

Completed

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Key information

Conditions

Ischaemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Countess of Chester Hospital NHS Foundation Trust, Chester, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult over 18
Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
No intracerebral haemorrhage as ruled out by computerised tomography (CT) or MRI scan.
Able to achieve a supine, sitting and semi-sitting position of 45° with the help of another person.
Receiving geko™ NMES treatment as standard of care for VTE prevention

Exclusion criteria

Inability to gain consent from the patient.
A transient ischaemic attack (TIA).
Stroke survivors with ischaemic stroke less than 7 days from onset.
History of epilepsy.
Below/above knee amputation.
History of established peripheral neuropathy.
Too unwell to participate as judged by physician.
Use of any other neuromodulation device that may interact with NMES

Treatment and study plan

Primary outcomes

Primary outcome

Time frame: 3 hours

a change in brain haemodynamics (or blood flow) in terms of oxygenated and de-oxygentated blood from baseline to end of study participation.

Secondary outcomes

Secondary objective

Time frame: 3 hours

Neurovascular coupling, Cerebral autoregulation and dynamic functional connectivity

Sponsors and collaborators

Lead sponsor

Countess of Chester NHS Foundation Trust

Other

Registry information

Official study title

MonitoRing the Effect of TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve on Cerebral Haemodynamics in Patients With Ischaemic Strokes. A Single Centre Prospective Study (Phase 1).

Acronym: RETRAIN

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 26, 2024
Registry last updated: Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed