Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02199795 : Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
PhasePhase 1
AgesMin: 21 Years Max: 75 Years
Eligibility
Inclusion Criteria:

- Age 21 to 75 years

- Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke

- Medically stable

- Unilateral lower extremity hemiparesis

- Ankle dorsiflexor strength of ?4/5 on the Medical Research Council scale, while
seated

- NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without
pain.

- Full voluntary ROM of the contralateral ankle

- Skin intact on bilateral lower extremities

- Able to don the NMES system or caregiver available to assist with device if needed.

- Able to hear and respond to stimulator auditory cues

- Able to follow 3-stage commands

- Able to recall 2 of 3 items after 30 minutes

- Cognition and communication adequate for safe use of the device based on neurological
assessment by physician principal investigator

Exclusion Criteria:

- Severely impaired cognition and communication

- History of peroneal nerve injury

- History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple
sclerosis

- Uncontrolled seizure disorder

- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)

- Edema of the paretic lower extremity

- Absent sensation of paretic lower extremity

- Evidence of deep venous thrombosis or thromboembolism

- History of cardiac arrhythmias with hemodynamic instability

- Cardiac pacemaker or other implanted electronic system

- Botulinum toxin injections to any lower extremity muscle in the last 3 months

- Pregnancy

- Symptomatic peripheral neuropathy

- Current use of psychoactive medications (except selective serotonin reuptake
inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants)

- Acetylcholinesterase inhibitor usage

- Unstable asthmatic condition

- Metallic implants (including clips and/or wires)

- Prosthetic heart valves

- Cardiac, renal or other stent

- History of claustrophobia

- Low visual acuity

- Body weight or body habitus not compatible to MRI machine

- Medical, psychological, or social concern identified by the principal investigator or
co-investigator which suggests inappropriateness of subject participation
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02199795      |      Link to official Clinicaltrials.gov listing
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