Completed

Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

transcranial direct current stim (tDCS)

+ transcranial direct current stim (tDCS)

Device
Who is being recruted

Brain Diseases+4

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: December 11, 2018
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity of Arkansas
Last updated: December 11, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
tDCS will be applied using a Soterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste. The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment]. The cathodal electrode will be placed over the contralateral motor cortex.

Group II

Placebo
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).

Study 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 Maps

University of Arkansas for Medical Sciences

Little Rock, United States
Completed2 Study Centers