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New treatment option for Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
Official title Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.
ClinicalTrials.gov ID: NCT07130929
What this study is testing
- What it's testing
- This study aims to evaluate the effectiveness of physiotherapy treatment combined with functional electrical stimulation (FES) in a small group of patients with severe acquired brain injury (SABI) of vascular origin and with a clinical and instrumental diagnosis of "Intensive Care Unit-Acquired Weakness" (ICU-AW). Functional electrical stimulation is a technology that uses electrical impulses, generated by an external device, to reactivate the neuromuscular system through electrodes applied to the skin.
- Time commitment: about 5 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, FI, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, FI, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.