Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients
transcranial direct current stim (tDCS)
+ transcranial direct current stim (tDCS)
Brain Diseases+4
+ Cardiovascular Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with assisted gait training is effective for improving gait in patients with chronic stroke.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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: >21 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. Demonstrate gait impairment 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. Pass the Transcranial Magnetic Stimulation (TMS) Adult Safety Screen (TASS) except for items related specifically to stroke and the treatment for stroke. 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. Documented episode in the medical record of a seizure occurring 1 month or more post stroke for which the patient received consultation or treatment for said seizures. Seizures occurring within the first month following a stroke are not exclusionary unless followed by another seizure. 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 Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry. 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. Additional Exclusion Criteria for MRI Scan Claustrophobia, or the inability to lie still in a confined space Major medical disorders (e.g., HIV, cancer) Medications which may affect image quality (e.g., water pills) Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the MRI scanner Non-removable dental implants, such as braces or permanent retainers, as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are OK) Permanent makeup or tattoos with metallic dyes A positive pregnancy test (for females), since the effect of strong magnetic fields on the developing fetus remains unknown and inconclusive. (We will conduct a pregnancy test for all female participants on the day of the MRI scan.) Psychotic disorders (e.g., schizophrenia) Any other condition that the investigator believes might put the participant at risk
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
University of Central Arkansas
Conway, United StatesOpen University of Central Arkansas in Google MapsUniversity of Arkansas for Medical Sciences
Little Rock, United States