Augmentation of Locomotor Adaptation Post-Stroke

NCT02892084 | Completed Phase 1

• 1 other identifier: 16060
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate two different methods of normalizing the center of mass acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of recovery to analyze walking-specific adaptations as precursors to motor learning. In addition, the proposed project seeks to establish the optimal configuration of electrodes to activate neural circuits involved in post-stroke locomotion. Once the better method of training COMa and optimal parameters of electrode placement for tDCS are identified, the investigators will evaluate the effects of tDCS on locomotor adaptations during single sessions and over a five-day training period.

Conditions

Stroke

Keywords

Chronic Stroke ( > 6 months); non-invasive brain stimulation; rehabilitation; walking; kinetics

Outcome Measures

Primary Outcomes (1)

• Center of Mass Acceleration Peak

  Peak full body center of mass acceleration during gait, expressed as m/sec\^2, captured during 30 seconds of treadmill walking at a steady-state, self-selected walking speed.

  Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

Secondary Outcomes (1)

• Center of Mass Acceleration Impulse

  Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

Other Outcomes (2)

• Self-selected walking speed

  Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

• Paretic step ratio

  Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.

Study Arms (2)

Uphill COMa training

EXPERIMENTAL

Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.

Device: tDCS; Device: Sham tDCS

Downhill COMa training

EXPERIMENTAL

Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.

Device: tDCS; Device: Sham tDCS

Interventions

tDCS DEVICE

Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain. Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.

Downhill COMa training; Uphill COMa training

Sham tDCS DEVICE

Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current. Evaluating immediate effects during 20 minutes walking on a treadmill.

Downhill COMa training; Uphill COMa training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-70
• at least six month post-stroke
• residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
• ability to sit unsupported for ≥ 30 sec
• ability to walk at least 10 ft.
• self-selected 10 meter gait speed \< 0.8 m/s
• provision of informed consent.

You may not qualify if:

• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking \< 200 meters
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• History of COPD or oxygen dependence
• Preexisting neurological disorders, dementia or previous stroke
• History of major head trauma
• Legal blindness or severe visual impairment
• history of significant psychiatric illness
• Life expectancy \<1 yr
• Severe arthritis or orthopedic problems that limit passive ROM
• post-stroke depression (PHQ-9 ≥10)
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
• presence of cerebellar stroke.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ralph H. Johnson VA Medical Center: collaborator

Study Sites (1)

MUSC Center for Rehabilitation Research in Neurologic Conditions

Charleston, South Carolina, 29425, United States

Location

Related Publications (24)

• Boggio PS, Nunes A, Rigonatti SP, Nitsche MA, Pascual-Leone A, Fregni F. Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Restor Neurol Neurosci. 2007;25(2):123-9.

  PMID: 17726271 BACKGROUND

• Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.

  PMID: 16456121 BACKGROUND

• Bowden MG, Behrman AL, Woodbury M, Gregory CM, Velozo CA, Kautz SA. Advancing measurement of locomotor rehabilitation outcomes to optimize interventions and differentiate between recovery versus compensation. J Neurol Phys Ther. 2012 Mar;36(1):38-44. doi: 10.1097/NPT.0b013e3182472cf6.

  PMID: 22333921 BACKGROUND

• Bowden MG, Clark DJ, Kautz SA. Evaluation of abnormal synergy patterns poststroke: relationship of the Fugl-Meyer Assessment to hemiparetic locomotion. Neurorehabil Neural Repair. 2010 May;24(4):328-37. doi: 10.1177/1545968309343215. Epub 2009 Sep 30.

  PMID: 19794132 BACKGROUND

• Brandell BR. Functional roles of the calf and vastus muscles in locomotion. Am J Phys Med. 1977 Apr;56(2):59-74.

  PMID: 851176 BACKGROUND

• Devanne H, Lavoie BA, Capaday C. Input-output properties and gain changes in the human corticospinal pathway. Exp Brain Res. 1997 Apr;114(2):329-38. doi: 10.1007/pl00005641.

  PMID: 9166922 BACKGROUND

• Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.

  PMID: 16148743 BACKGROUND

• Hummel F, Cohen LG. Improvement of motor function with noninvasive cortical stimulation in a patient with chronic stroke. Neurorehabil Neural Repair. 2005 Mar;19(1):14-9. doi: 10.1177/1545968304272698.

  PMID: 15673839 BACKGROUND

• Jeffery DT, Norton JA, Roy FD, Gorassini MA. Effects of transcranial direct current stimulation on the excitability of the leg motor cortex. Exp Brain Res. 2007 Sep;182(2):281-7. doi: 10.1007/s00221-007-1093-y. Epub 2007 Aug 24.

  PMID: 17717651 BACKGROUND

• Kim DY, Lim JY, Kang EK, You DS, Oh MK, Oh BM, Paik NJ. Effect of transcranial direct current stimulation on motor recovery in patients with subacute stroke. Am J Phys Med Rehabil. 2010 Nov;89(11):879-86. doi: 10.1097/PHM.0b013e3181f70aa7.

  PMID: 20962598 BACKGROUND

• Lay AN, Hass CJ, Gregor RJ. The effects of sloped surfaces on locomotion: a kinematic and kinetic analysis. J Biomech. 2006;39(9):1621-8. doi: 10.1016/j.jbiomech.2005.05.005. Epub 2005 Jun 28.

  PMID: 15990102 BACKGROUND

• Leroux A, Fung J, Barbeau H. Postural adaptation to walking on inclined surfaces: II. Strategies following spinal cord injury. Clin Neurophysiol. 2006 Jun;117(6):1273-82. doi: 10.1016/j.clinph.2006.02.012. Epub 2006 Apr 27.

  PMID: 16644275 BACKGROUND

• Leroux A, Fung J, Barbeau H. Postural adaptation to walking on inclined surfaces: I. Normal strategies. Gait Posture. 2002 Feb;15(1):64-74. doi: 10.1016/s0966-6362(01)00181-3.

  PMID: 11809582 BACKGROUND

• Shah B, Nguyen TT, Madhavan S. Polarity independent effects of cerebellar tDCS on short term ankle visuomotor learning. Brain Stimul. 2013 Nov;6(6):966-8. doi: 10.1016/j.brs.2013.04.008. Epub 2013 May 17.

  PMID: 23711765 BACKGROUND

• Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.

  PMID: 14677402 BACKGROUND

• Peterson CL, Cheng J, Kautz SA, Neptune RR. Leg extension is an important predictor of paretic leg propulsion in hemiparetic walking. Gait Posture. 2010 Oct;32(4):451-6. doi: 10.1016/j.gaitpost.2010.06.014. Epub 2010 Jul 24.

  PMID: 20656492 BACKGROUND

• Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.

  PMID: 21968548 BACKGROUND

• Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.

  PMID: 19164589 BACKGROUND

• Roberts DR, Ramsey D, Johnson K, Kola J, Ricci R, Hicks C, Borckardt JJ, Bloomberg JJ, Epstein C, George MS. Cerebral cortex plasticity after 90 days of bed rest: data from TMS and fMRI. Aviat Space Environ Med. 2010 Jan;81(1):30-40. doi: 10.3357/asem.2532.2009.

  PMID: 20058735 BACKGROUND

• Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.

  PMID: 19064743 BACKGROUND

• Tanaka S, Hanakawa T, Honda M, Watanabe K. Enhancement of pinch force in the lower leg by anodal transcranial direct current stimulation. Exp Brain Res. 2009 Jul;196(3):459-65. doi: 10.1007/s00221-009-1863-9. Epub 2009 May 29.

  PMID: 19479243 BACKGROUND

• Tanaka S, Takeda K, Otaka Y, Kita K, Osu R, Honda M, Sadato N, Hanakawa T, Watanabe K. Single session of transcranial direct current stimulation transiently increases knee extensor force in patients with hemiparetic stroke. Neurorehabil Neural Repair. 2011 Jul-Aug;25(6):565-9. doi: 10.1177/1545968311402091. Epub 2011 Mar 24.

  PMID: 21436391 BACKGROUND

• Turns LJ, Neptune RR, Kautz SA. Relationships between muscle activity and anteroposterior ground reaction forces in hemiparetic walking. Arch Phys Med Rehabil. 2007 Sep;88(9):1127-35. doi: 10.1016/j.apmr.2007.05.027.

  PMID: 17826457 BACKGROUND

• Werner C, Lindquist AR, Bardeleben A, Hesse S. The influence of treadmill inclination on the gait of ambulatory hemiparetic subjects. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):76-80. doi: 10.1177/1545968306289958.

  PMID: 17172557 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mark G Bowden, PhD, PTf

  Ralph H. Johnson VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: May 3, 2016
• First Posted: September 8, 2016
• Study Start: April 1, 2013
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)