Transcranial Direct Current Stimulation for Improving Gait Training in Stroke

Completed

Phase N/A Results N/A

Update History

22 Nov '17
The Summary of Purpose was updated.
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The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with functional electrical stimulation assisted gait training (FESAGT) is effective for improving gait in patients with chronic stroke.
Old
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with functional electrical stimulation assisted gait training (FESAGT) is effective for improving gait in patients with chronic stroke.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Inclusion Criteria: - Stroke survivors > 3 months from most recent unilateral, stroke based on clinically or experimentally obtained MRI brain scans and behavioral evidence of stroke (e.g., risk factors, hemiplegia, unilateral sensory impairment, or localized higher cortical dysfunction) by report or in the medical record. - Age: >30 years of age. - Complete NIH Stroke Scale. - Sufficient endurance, motor ability and balance to ambulate at least 10 meters continuously with moderate or less assistance. - Have ankle dorsiflexion passive range of motion to 0° or greater. - Demonstrate foot-drop during ambulation such that gait instability or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited. - Ankle dorsiflexion to at least neutral while standing in response to neuromuscular electrical stimulation (NMES) of the common peroneal nerve without painful hypersensitivity to the NMES. - Pass the Transcranial Magnetic Stimulation (TMS) Adult Safety Screen (TASS). Exclusion Criteria: - Edema, skin breakdown, absent sensation of the affected lower limb which interferes with the peroneal nerve stimulator. - History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability. - Demand pacemakers or any other implanted electronic systems. - Pregnant women, uncontrolled seizure disorder, Parkinson's Disease, Spinal cord injury, Traumatic brain injury with evidence of motor weakness, Multiple sclerosis. - Fixed ankle plantar flexor contracture, peroneal nerve injury at the fibular head as the cause of foot-drop. - History of dementia, severely impaired cognition, communication or comprehension deficits. - Presence of severe or frequent headaches - History of painful hypersensitivity to NMES of the common peroneal nerve. - History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry. - Receiving other forms of electrical stimulation. - Have other medical conditions or are taking medications that compromise ambulation or balance. - Failure to meet established screening criteria for TMS or tDCS (i.e., TASS) - Principal Investigator's or Medical Monitor's discretion not to include a participant
Old
Inclusion Criteria: - Stroke survivors > 3 months from most recent unilateral, stroke based on clinically or experimentally obtained MRI brain scans and behavioral evidence of stroke (e.g., risk factors, hemiplegia, unilateral sensory impairment, or localized higher cortical dysfunction) by report or in the medical record. - Age: >30 years of age. - Complete NIH Stroke Scale. - Sufficient endurance, motor ability and balance to ambulate at least 10 meters continuously with moderate or less assistance. - Have ankle dorsiflexion passive range of motion to 0° or greater. - Demonstrate foot-drop during ambulation such that gait instability or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited. - Ankle dorsiflexion to at least neutral while standing in response to neuromuscular electrical stimulation (NMES) of the common peroneal nerve without painful hypersensitivity to the NMES. - Pass the Transcranial Magnetic Stimulation (TMS) Adult Safety Screen (TASS). Exclusion Criteria: - Edema, skin breakdown, absent sensation of the affected lower limb which interferes with the peroneal nerve stimulator. - History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability. - Demand pacemakers or any other implanted electronic systems. - Pregnant women, uncontrolled seizure disorder, Parkinson's Disease, Spinal cord injury, Traumatic brain injury with evidence of motor weakness, Multiple sclerosis. - Fixed ankle plantar flexor contracture, peroneal nerve injury at the fibular head as the cause of foot-drop. - History of dementia, severely impaired cognition, communication or comprehension deficits. - Presence of severe or frequent headaches - History of painful hypersensitivity to NMES of the common peroneal nerve. - History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry. - Receiving other forms of electrical stimulation. - Have other medical conditions or are taking medications that compromise ambulation or balance. - Failure to meet established screening criteria for TMS or tDCS (i.e., TASS) - Principal Investigator's or Medical Monitor's discretion not to include a participant
A location was updated in Conway.
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The overall status was removed for University of Central Arkansas.
A location was updated in Little Rock.
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The overall status was removed for University of Arkansas for Medical Sciences.
12 Sep '13
A location was updated in Conway.
New
The overall status was removed for University of Central Arkansas.
A location was updated in Little Rock.
New
The overall status was removed for University of Arkansas for Medical Sciences.