The RETRAIN Trial (Phase 1)

Completed

• Conditions: Ischaemic Stroke

• Registration Number: NCT06614400
• Lead Sponsor: Countess of Chester NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-26
• Study Start: 2024-10-08
• Status Verified: 2025-03
• Primary Completion: 2025-03-08
• Study Completion: 2025-03-18
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary objective	3 hours	Neurovascular coupling, Cerebral autoregulation and dynamic functional connectivity

Trial Locations

Locations (1)

Countess of Chester Hospital NHS Foundation Trust; 🇬🇧 Chester, Cheshire, United Kingdom