The RETRAIN Trial (Phase 1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-03-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischaemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No