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Spinal Cord InjuriesNCT03237234

Enhancing Corticospinal Activation for Improved Walking Function

A study testing Motor Skill Training and Transcranial direct current stimulation (tDCS) in people with Spinal Cord Injuries, run by Shepherd Center, Atlanta GA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Motor Skill Training and Transcranial direct current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
1 Mar 2017to 1 Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Shepherd Center, Inc.

    Atlanta, Georgia, 30309

Other trials in United States

About this study

Official title: SCIMS Project 1: Enhancing Corticospinal Activation for Improved Walking Function

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.

Read the 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.

Being tested
Motor Skill Training, Transcranial direct current stimulation (tDCS)
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Skill TrainingOther

    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.

  • Transcranial direct current stimulation (tDCS)Device

    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.

Study groups in NCT03237234
Study groupRoleWhat they receive
Motor Training + Sham tDCSSham comparatorIndividuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (tDCS).
Receives: Other: Motor Skill Training
Motor Training + tDCSExperimentalIndividuals 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.
Receives: Other: Motor Skill Training; Device: Transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10 Meter Walk Test (Walk Speed)

    Walking speed was the primary outcome measure for walking function, as speed has been the standard measure used in the literature and allowed us to assess outcomes relative to other published studies. Walking speed was determined using the 10-Meter Walk Test. Participants completed 3 walk trials at each time point, separated by 2 minutes of seated rest. The average walking speed of 3 walks was calculated and used in the analyses. Data reported were obtained at baseline at Day 1 (D1) and at follow-up on Day 5 (D5), 24-hours post-intervention.

    Measured: D1, D5

Secondary outcomes (11)
  1. Spatiotemporal Gait Characteristic (Cadence)

    Gait quality was quantified by spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] and step length [cm] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Cadence for each walk trial was computed using the GAITRite system, and the average cadence across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  2. Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb)

    Gait quality was quantified by spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] and step length [cm] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the weaker limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  3. Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb)

    Gait quality was quantified by spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] and step length [cm] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the stronger limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  4. Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)

    Step length [cm] of the weaker and stronger limbs were collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average step length of each lower limb for each walk trial was computed from data obtained from the GAITRite system. Lower limbs were classified as stronger or weaker according to manual muscle test scores collected at baseline (D1). The average step length for the stronger and weaker limbs was used to calculate the step symmetry index (SI) using the following formula: SI = ((SLs - SLw)/0.5(SLs + SLw)) x 100; where SLs = stronger limb stride length and SLw = weaker limb stride length. Final values are reported as the absolute % of the ratio difference in step length between the stronger and weaker limbs. A SI value of 0% indicates perfect interlimb step symmetry. Higher SI values indicate greater interlimb step length asymmetry.

    Measured: D1, D5

  5. Maximal Isometric Dorsiflexor Strength

    Ankle dorsiflexion (tibialis anterior) strength was measured with the subject seated and 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 force was calculated based on the highest force measured over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  6. Berg Balance Scale

    Balance was measured using the Berg Balance Scale (BBS), which has been found to be valid for use in persons with SCI. The BBS total score was calculated for each participant at each time point, and the median score for each group was calculated. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  7. Falls Efficacy Scale-International Version (FES-I)

    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 was an important factor to consider relative to the mobility interventions employed in the present study. The FES-I total score was calculated for each participant at each time point, and the median for each group was recorded. The total range of scores possible for the FES-I is equal to 16-64, with lower total scores indicating decreased fear of falling. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  8. Spinal Cord Assessment Tool for Spastic Reflexes

    The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) was used to assess the impact of motor skill training + sham stimulation and motor training + tDCS on spasticity. SCATS is well correlated with electrophysiological measures of spasticity and is better correlated with self-reported measures of spasm frequency than the Ashworth test. Total SCATS scores for each limb were summed and median values were obtained for each group. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater spasticity severity. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  9. Modified 5-Times Sit-to-Stand

    The modified 5-times sit-to-stand test was used as a measure of functional lower extremity strength. In this test, the participant was 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) was recorded. The average time to complete the test was calculated at each time point for each group. Lower sit-to-stand times indicate greater functional lower extremity strength. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  10. Maximal Isometric Quadriceps Strength

    Knee extensor (quadriceps) strength was measured with participants 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 force was analyzed based on the maximum force produced over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

  11. 2 Minute Walk Test

    Functional walking capacity was measured based on 2-minute walk test distance. The use of the 2-minute rather than the 6-minute walk test allowed us to include individuals whose impairments result in inability to walk for 6 minutes. Total distance walked in 2-minutes was recorded for each participant at each time point, and the average distance was calculated for each group. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.

    Measured: D1, D5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2017
  2. Study start1 Mar 2017
  3. Primary completion1 Mar 2020
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03237234
Sponsor's protocol ID
SCIMS1-703
Status last verified
Dec 2021
First submitted
13 Jul 2017
Last updated
12 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Evans NH, Suri C, Field-Fote EC. Walking and Balance Outcomes Are Improved Following Brief Intensive Locomotor Skill Training but Are Not Augmented by Transcranial Direct Current Stimulation in Persons With Chronic Spinal Cord Injury. Front Hum Neurosci. 2022 May 11;16:849297. doi: 10.3389/fnhum.2022.849297. eCollection 2022.

    PubMed 35634208
  • Evans NH, Field-Fote EC. A Pilot Study of Intensive Locomotor-Related Skill Training and Transcranial Direct Current Stimulation in Chronic Spinal Cord Injury. J Neurol Phys Ther. 2022 Oct 1;46(4):281-292. doi: 10.1097/NPT.0000000000000403. Epub 2022 May 11.

    PubMed 35544283

Questions about this trial

What is this clinical trial studying?

A study testing Motor Skill Training and Transcranial direct current stimulation (tDCS) in people with Spinal Cord Injuries, run by Shepherd Center, Atlanta GA at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10 Meter Walk Test (Walk Speed) (time frame: D1, D5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03237234, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.

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Clinical Trial NCT03237234 | AzTrials