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Shock to the system: electrical zaps may help stroke patients walk again

NCT ID NCT07130929

Symptom relief Sponsor: Fondazione Don Carlo Gnocchi Onlus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding gentle electrical stimulation to physical therapy can help people who have had a severe stroke and developed muscle weakness in the ICU. About 24 participants will receive either standard therapy or therapy combined with functional electrical stimulation (FES) for 5 weeks. The goal is to see if FES improves leg strength and movement better than therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of ischemic or hemorrhagic vascular GCA involving unilateral motor deficit \< 3 months; * Premorbid Modified Rankin Scale \<2; * Age \>18 years and \<80 years; * Level of Cognitive Functioning \> 4 for active participation in treatment. * MRC total sum score \<= 48 (range 0 -60) for clinical suspicion of ICU-AW * Clinical diagnosis of tetra/paraparesis of peripheral origin confirmed by neurophysiological examination; * Signature of informed consent by the patient or, if incapacitated, by their legal representative. Exclusion Criteria: * Clinical cardio-respiratory or internal instability such as to prevent treatment; * History of previous comorbidity for ICU-AW; * Previous known chronic neuropathy; * Severe coagulopathy; * Skin integrity problems at the interface surfaces with the electrostimulator; * Epilepsy not controlled by medication; * Presence of implanted electronic devices; * Pregnancy or breastfeeding; * Severe spasticity with a score of \>3 on the modified Ashworth scale; * Treatment with botulinum toxin; * Recent malignant neoplasm; * Conditions that put you at risk for neuropathies, e.g., history of diabetes mellitus, renal failure, hepatic failure, vitamin deficiencies, chronic alcoholism, vasculitis, previous use of neurotoxic drugs.

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Conditions

The condition(s) this trial relates to.

brain injury critical illness polyneuropathy stroke disorder vascular brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired brain injury including stroke Intensive care unit (ICU) acquired weakness (icu - aw)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS-Fondazione Don Gnocchi

    RECRUITING

    Florence, FI, 50143, Italy

More trials for these conditions

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