Ischaemic StrokeRETRAINNCT06614400
The RETRAIN Trial (Phase 1)
An observational study of Ischaemic Stroke, run by Countess of Chester NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Stroke
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Oct 2024to 18 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (over 18 years) with ischaemic stroke more than 7 days from onset
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Countess of Chester Hospital NHS Foundation Trust
Chester, Cheshire, CH2 1UL
Countess of Chester Hospital NHS Foundation Trust
Chester, Cheshire, CH4 7PB
About this study
Official title: 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).
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
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (1)
Secondary objective
Neurovascular coupling, Cerebral autoregulation and dynamic functional connectivity
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start8 Oct 2024
- Primary completion8 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614400
- Sponsor's protocol ID
- 343056
- Acronym
- RETRAIN
- Status last verified
- Mar 2025
- First submitted
- 28 Aug 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No identifiable patient data will be shared, only the findings of the procedure.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06614400
- Acronym / sponsor ID
- RETRAIN / 343056
- Conditions
- Ischaemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (over 18 years) with ischaemic stroke more than 7 days from onset
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome
Time frame: 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.
1 secondary outcome
Secondary objective
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided. No identifiable patient data will be shared, only the findings of the procedure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Stroke, run by Countess of Chester NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.