Transcranial Direct Current Stimulation for Improving Gai... | NCT01807637

NCT01807637

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
138159	Other Identifier	University of Arkansas for Medical Sciences

Status Module

Name	Class
University of Central Arkansas	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).	A Magstim 200 super rapid2 stimulator with a 110 mm double cone coil will deliver stimulation. First, the TMS motor threshold (MT) will be established and the best location for eliciting MEPs from the contralesional and ipsilesional TA muscle will be tracked on the subject's MRI scan in Brainsight. Recruitment curves will be obtained as follows: 1) delivering ten, single TMS pulses beginning at 70% of MT, 2) increasing TMS intensity by 10% and repeating the process up to 160% of the MT or until a plateau in the recruitment curve is reached, 3) offline data processing will be performed with the Matlab curve fitting toolbox and 4) the threshold, slope, and MEPmax, and the goodness of fit (R2) will be calculated. A change in the slope of the recruitment curve will indicate change in cortical excitability.

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Mark Mennemeier, PhD	University of Arkansas	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Central Arkansas		Conway	Arkansas	72035	United States
University of Arkansas for Medical Sciences

PubMed Identifier	Type	Citation	Retractions
33175411	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Transcranial Direct Current Stim	tDCS will be applied using a DeluxeSoterix 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. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
FG001	Sham tDCS	Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Transcranial Direct Current Stim	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. transcranial direct current stim (tDCS): 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Error

degrees

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

ID	Title	Description
OG000	Active tDCS: Week 5 - Baseline.	tDCS will be applied using a DeluxeSoterix 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. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Transcranial Direct Current Stim	tDCS will be applied using a DeluxeSoterix 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. During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases