Clinical trial NCT03237234: Enhancing Corticospinal Activation for Improved Walking Function
Official title: SCIMS Project 1: Enhancing Corticospinal Activation for Improved Walking Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2017-08-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 10 Meter Walk Test (Walk Speed)
timeFrame: D1, D5
Secondary outcomes:
measure: Spatiotemporal Gait Characteristic (Cadence)
timeFrame: D1, D5
measure: Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb)
timeFrame: D1, D5
measure: Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb)
timeFrame: D1, D5
measure: Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
timeFrame: D1, D5
measure: Maximal Isometric Dorsiflexor Strength
timeFrame: D1, D5
measure: Berg Balance Scale
timeFrame: D1, D5
measure: Falls Efficacy Scale-International Version (FES-I)
timeFrame: D1, D5
measure: Spinal Cord Assessment Tool for Spastic Reflexes
timeFrame: D1, D5
measure: Modified 5-Times Sit-to-Stand
timeFrame: D1, D5
measure: Maximal Isometric Quadriceps Strength
timeFrame: D1, D5
measure: 2 Minute Walk Test
timeFrame: D1, D5
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center, Inc.
state: Georgia
Study officials:
References:
citation: 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.
citation: 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.