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Enhancing Corticospinal Activation for Improved Walking Function

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ClinicalTrials.gov Identifier: NCT03237234
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Edelle Field-Fote, Shepherd Center, Atlanta GA

Brief Summary:
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive brain stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with brain stimulation may further enhance the restoration of function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Motor Skill Training Device: Transcranial direct current stimulation (tDCS) Not Applicable

Detailed Description:

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve access to intensive training programs, facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, research suggests that enhancing brain excitability might have benefits for improving the communication between the brain and spinal cord. Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that has been shown to directly increase brain excitability, which may make it easier for the brain and nervous system to respond to training. Combining motor skill exercises with brain stimulation may enhance the restoration of walking function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.

Participants in the proposed study will complete one baseline testing session, 3 motor training sessions, and one follow-up session over 5 consecutive days. During the first and fifth sessions, participants will complete assessments only, which will take approximately 2-3 hours each day. During the second, third, and fourth sessions, participants will perform a series of 6 standing motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Participants will be randomized to either a motor training only group or a motor training + tDCS group. The motor training + tDCS group will receive brain stimulation during the motor skill training, while the motor training only group will receive sensory level brain stimulation only. Each participant will complete the 6 motor skill exercise circuit 4 times. Motor training exercise sessions will last approximately 25-30 minutes and will be preceded and followed by assessments of walking function, spasticity, and ankle strength in order to determine changes in these measures over time.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SCIMS Project 1: Enhancing Corticospinal Activation for Improved Walking Function
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Motor Training + Sham tDCS
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (tDCS).
Other: Motor Skill Training
Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.

Experimental: Motor Training + tDCS
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (tDCS) delivered at 2mA to the motor cortex.
Other: Motor Skill Training
Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.

Device: Transcranial direct current stimulation (tDCS)
The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MT activities. As reported previously, participants in the MT-only group will receive sham tDCS to maintain analogous study procedures.




Primary Outcome Measures :
  1. 10 Meter Walk Test [ Time Frame: Days 1-5 ]
    Walking speed will be the primary outcome measure for walking function, as speed has been the standard measure used in the literature and will allow us to assess outcomes relative to other published studies. Walking speed will be determined using the 10 Meter Walk Test, which will be recorded as the average time across 3 trials that a participant can walk a 10 meter distance.

  2. Maximal Isometric Dorsiflexor Strength [ Time Frame: Days 1-5 ]
    Ankle dorsiflexion (tibialis anterior) strength will be measured with the subject seated, with the test foot strapped to a handheld dynamometer. An ankle dorsiflexion test was selected based on evidence indicating that the tibialis anterior is under the greatest corticospinal control. Maximum dorsiflexion torque will be calculated based on the highest of three attempts.

  3. Gait Kinematics [ Time Frame: Days 1-5 ]
    Kinematic data related to walking performance will be obtained using an accelerometer-based motion capture system (Xsens MVN Biomech Awinda, Xsens, Enschede, Netherlands) as the subject walks along a 12-meter path, using only the passive assistive devices they typically use (e.g., lower limb orthotics, walker, forearm crutches). Secondarily, we will assess gait quality as reflected by step height, step length, and step symmetry.


Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: Day 1, Day 5 ]
    Balance will be measured using the Berg Balance Scale, which has been found to be valid for use in persons with SCI.

  2. Falls Efficacy Scale-International Version [ Time Frame: Day 1, Day 5 ]
    The fear of falling may be a major concern for persons with mobility impairments and may limit one's confidence or ability to perform activities of daily living. Fear of falling may also limit an individual's performance of specific overground motor tasks irrespective of functional ability to perform that task. Therefore, the fear of falling will be an important factor to consider relative to the mobility interventions employed in the present study.

  3. Spinal Cord Assessment Tool for Spastic Reflexes [ Time Frame: Days 1-5 ]
    We will use the Spinal Cord Assessment Tool for Spastic Reflexes to assess the impact of MT-only and MT+tDCS on spasticity. This measure is well correlated with electrophysiological measures of spasticity and is better correlated with self-reported measures of spasm frequency than the Ashworth test.

  4. Modified 5-Times Sit-to-Stand [ Time Frame: Day 1, Day 5 ]
    The modified 5-times sit-to-stand test will be used a measure of functional lower extremity strength. In this test, the subject is seated on a mat table with height adjusted to 80% of lower extremity length. The time required to complete 5 repetitions of standing up and sitting down (without using the upper extremities for assistance) is recorded.

  5. Maximal Isometric Quadriceps Strength [ Time Frame: Day 1, Day 5 ]
    Knee extensor (quadriceps) strength will be measured with the subject seated, with the test leg strapped to a handheld dynamometer. Prior studies have shown that a single session of tDCS improves quadriceps strength in persons with stroke. Maximum knee extensor torque will be calculated based on the highest of three attempts.

  6. 2 Minute Walk Test [ Time Frame: Day 1, Day 5 ]
    Functional walking capacity will be measured based on 2-minute walk test distance. The use of the 2-minute rather than the 6-minute walk test allows us to include individuals whose impairments result in inability to walk for 6 minutes.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a spinal cord injury (neurological level C3-T10);
  • Chronic SCI (12 months or greater);
  • Neurological impairment classification C or D;
  • Able to stand for at least 5 minutes (with or without an assistive device);
  • Able to move each leg independently for at least 3 steps;
  • Able to rise from sit to stand with moderate assistance from one person;
  • Ability and willingness to consent and authorize use of personal health information.

Exclusion Criteria:

  • Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord;
  • Injuries below the neurological spinal level of T10;
  • History of cardiovascular irregularities;
  • Altered cognitive status;
  • Presence of orthopedic conditions that would adversely affect participation in exercise;
  • Implanted metallic objects in the head;
  • History of seizures;
  • Inability and unwillingness to consent and authorize use of personal health information.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237234


Locations
United States, Georgia
Shepherd Center, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: Edelle Field-Fote, PT, PhD, FAPTA    (404) 603-4274    Edelle_Field-Fote@Shepherd.org   
Contact: Nicholas H Evans, MHS    404-350-7742    nicholas_evans@shepherd.org   
Sponsors and Collaborators
Shepherd Center, Atlanta GA
National Institute on Disability, Independent Living, and Rehabilitation Research

Responsible Party: Edelle Field-Fote, Director of Spinal Cord Injury Research, Shepherd Center, Atlanta GA
ClinicalTrials.gov Identifier: NCT03237234     History of Changes
Other Study ID Numbers: SCIMS1-703
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries