Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients
transcranial direct current stim (tDCS)
+ transcranial direct current stim (tDCS)
Maladies du cerveau+4
+ Maladies Cardiovasculaires
+ Maladies du système nerveux central
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2013
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.6 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 21 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
ExpérimentalGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
University of Central Arkansas
Conway, United StatesOuvrir University of Central Arkansas dans Google MapsUniversity of Arkansas for Medical Sciences
Little Rock, United States