The RETRAIN Trial (Phase 1)

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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06614400

Acronym

RETRAIN

Enrollment

Registered

2024-09-26

Start date

2024-10-08

Completion date

2025-03-18

Last updated

2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic Stroke

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary outcome	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

Measure	Time frame	Description
Secondary objective	3 hours	Neurovascular coupling, Cerebral autoregulation and dynamic functional connectivity

Countries

United Kingdom

Outcome results