Clinical trial NCT02199795: Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Official title: Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Footdrop
Keywords: stroke
hemiplegia
footdrop
electrical stimulation
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Case Western Reserve University
First posted: 2014-07-24
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a small pilot randomized controlled trial which will enroll both subacute (\<6 mos) and chronic (\>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Lower Extremity Fugl-Meyer Score at End of Treatment
timeFrame: Baseline and End of Treatment (6 weeks)
Secondary outcomes:
measure: Change in 10-Meter Walk Test
timeFrame: Baseline and End of Treatment (6 weeks)
measure: Change in Ankle Movement Tracking Error at End of Treatment
timeFrame: Baseline and End of Treatment (6 weeks)
measure: Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
timeFrame: Baseline and End of Treatment (6 weeks)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Lynne R. Sheffler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16.
citation: Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.
citation: Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.
citation: Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22.
citation: Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23.