Transcranial Direct Current Stimulation for Improving Gait Training in Stroke

NCT01807637 | Completed Results DMC

• 1 other identifier: 138159
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Cerebral Vascular Accident

Outcome Measures

Primary Outcomes (1)

• Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait

  Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35. 2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany). LED markers are placed on the participant's lower extremity. Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments. Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.

  Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).

Secondary Outcomes (2)

• Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).

  Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).

• Change From Baseline in Stroke Impact Scale Scores

  Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).

Study Arms (2)

transcranial direct current stim

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.

Device: transcranial direct current stim (tDCS)

sham tDCS

PLACEBO COMPARATOR

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

Device: transcranial direct current stim (tDCS)

Interventions

transcranial direct current stim (tDCS) DEVICE

During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off.

sham tDCS; transcranial direct current stim

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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

Sponsors & Collaborators

• University of Arkansas: lead
• University of Central Arkansas: collaborator

Study Sites (2)

University of Central Arkansas

Conway, Arkansas, 72035, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mark Mennemeier, PhD
• Organization: University of Arkansas for Medical Sciences

msmennemeier@uams.edu

15015267773

Study Officials

• Mark Mennemeier, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: March 1, 2013
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: December 11, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-11

Locations

US (2)