The RETRAIN Trial (Phase 1)

Countess of Chester NHS Foundation Trust

Status: Completed

Conditions: Ischaemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT06614400

343056

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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