The RETRAIN Trial (Phase 1)

NCT06614400 | Completed

• 1 other identifier: 343056
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischaemic Stroke

Outcome Measures

Primary Outcomes (1)

• Primary outcome

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

  3 hours

Secondary Outcomes (1)

• Secondary objective

  3 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (over 18 years) with ischaemic stroke more than 7 days from onset

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Countess of Chester NHS Foundation Trust: lead

Study Sites (2)

Countess of Chester Hospital NHS Foundation Trust

Chester, Cheshire, CH2 1UL, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, Cheshire, CH4 7PB, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 26, 2024
• Study Start: October 8, 2024
• Primary Completion: March 8, 2025
• Study Completion: March 18, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

GB (2)