Transcranial Direct Current Stimulation for Improving Gait Training in Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Arkansas
Sponsor:
Collaborator:
University of Central Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01807637
First received: March 6, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stroke
Cerebral Vascular Accident
Device: transcranial direct current stim

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • change from baseline in ankle dorsiflexion angle during the swing phase of gait [ Time Frame: baseline, and one week, one month, and six months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in slope of cortical recruitment curve [ Time Frame: baseline, and 1 week, 1 month, and 6 month post intervention ] [ Designated as safety issue: No ]
    The cortical recruitment curve slope will be derived from plots of motor-evoked potentials (MEPs) recorded from the contralesional tibialis anterior muscle. MEPs are elicited by single-pulse transcranial magnetic stimulation delivered at increasing intensity over the lower extremity motor cortex.

  • change from baseline in Stroke impact scale scores [ Time Frame: baseline, and 1 week, 1 month, and 6 moths post intervention ] [ Designated as safety issue: No ]
    The Stroke Impact Scale (SIS) is a standardized assessment of strength, hand function, ADL/IADL, mobility, communication, emotion, cognition, and social and occupational engagement. It consists of 64 - 5 point likert scale questions with a total score range of 64(lowest) to 320 (highest).


Estimated Enrollment: 88
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial direct current stim
tDCS will be applied using a Life-Tech®, Iontophor PM Deluxe constant current stimulator with carbon rubber electrodes encased in saline (0.9% NaCl) soaked sponges that measure 5 x 5 cm (25cm2) for the anode and 5x7 for the cathode (35cm2). The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere. The cathodal electrode will be placed over the contralateral supraorbital region.
Device: transcranial direct current stim
tDCS will be applied using a Life-Tech®, Iontophor PM Deluxe constant current stimulator with carbon rubber electrodes encased in saline (0.9% NaCl) soaked sponges that measure 5 x 5 cm (25cm2) for the anode and 5x7 for the cathode (35cm2). The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere. The cathodal electrode will be placed over the contralateral supraorbital region.
Placebo Comparator: sham tDCS
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: >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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807637

Contacts
Contact: Chad I Lairamore, PhD 501-450-5597 chadl@uca.edu

Locations
United States, Arkansas
University of Central Arkansas Recruiting
Conway, Arkansas, United States, 72035
Contact: Chad Lairamore, PhD    501-450-5597    chadl@uca.edu   
Sub-Investigator: Chad Lairamore, PhD         
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Mark Mennemeier, PhD    501-526-7773    MSMennemeier@uams.edu   
Principal Investigator: Mark Mennemeier, PhD         
Sponsors and Collaborators
University of Arkansas
University of Central Arkansas
Investigators
Principal Investigator: Mark Mennemeier, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01807637     History of Changes
Other Study ID Numbers: 138159, 138159
Study First Received: March 6, 2013
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014